Sling delivery system and method of use

ABSTRACT

An apparatus and method of use are disclosed to treat urological disorders. The biocompatible device includes a handle, needle, dilator and sling assembly configured to be minimally invasive and provide sufficient support to the target site. In addition, the configuration of the sling assembly also allows the sling to be adjusted during and/or after implantation. The device and treatment procedure are highly effective and produce little to no side effects or complications. Further, operative risks, pain, infections and post operative stays are reduced, thereby improving patient quality of life.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority of U.S. provisional applicationSer. No. 60/263,472, filed Jan. 23, 2001; and U.S. provisionalapplication Ser. No. 60/269,829, filed Feb. 20, 2001; and U.S.provisional application Ser. No. 60/281,350, filed Apr. 4, 2001; andU.S. provisional application Ser. No. 60/295,068, filed Jun. 1, 2001;and U.S. provisional application Ser. No. 60/306,915, filed Jul. 20,2001, each of whose contents are fully incorporated herein by reference.

BACKGROUND

Over 13 million American men and women of all ages suffer from urinaryincontinence. The social implications for an incontinent patient includeloss of self-esteem, embarrassment, restriction of social and sexualactivities, isolation, depression and, in some instances, dependence oncaregivers. Incontinence is the most common reason forinstitutionalization of the elderly.

The urinary system consists of the kidneys, ureters, bladder andurethra. The bladder is a hollow, muscular, balloon-shaped sac thatserves as a storage container for urine. The bladder is located behindthe pubic bone and is protected by the pelvis. Ligaments hold thebladder in place and connect it to the pelvis and other tissue. FIG. 2schematically illustrates female anatomy. The urethra 16 is the tubethat passes urine from the bladder 14 out of the body. The narrow,internal opening of the urethra 16 within the bladder 14 is the bladderneck 18. In this region, the bladder's bundled muscular fiberstransition into a sphincteric striated muscle called the internalsphincter. FIG. 3 schematically illustrates male anatomy. The urethra 16extends from the bladder neck 18 to the end of the penis 22. The maleurethra 16 is composed of three portions: the prostatic, bulbar andpendulus portions. The prostatic portion is the widest part of the tube,which passes through the prostate gland 24.

Incontinence may occur when the muscles of the urinary systemmalfunction or are weakened. Other factors, such as trauma to theurethral area, neurological injury, hormonal imbalance or medicationside-effects, may also cause or contribute to incontinence. There arefive basic types of incontinence: stress incontinence, urgeincontinence, mixed incontinence, overflow incontinence and functionalincontinence. Stress urinary incontinence (SUI) is the involuntary lossof urine that occurs due to sudden increases in intra-abdominal pressureresulting from activities such as coughing, sneezing, lifting,straining, exercise and, in severe cases, even simply changing bodyposition. Urge incontinence, also termed “hyperactive bladder”“frequency/urgency syndrome” or “irritable bladder,” occurs when anindividual experiences the immediate need to urinate and loses bladdercontrol before reaching the toilet. Mixed incontinence is the mostcommon form of urinary incontinence. Inappropriate bladder contractionsand weakened sphincter muscles usually cause this type of incontinence.Mixed incontinence is a combination of the symptoms for both stress andurge incontinence. Overflow incontinence is a constant dripping orleakage of urine caused by an overfilled bladder. Functionalincontinence results when a person has difficulty moving from one placeto another. It is generally caused by factors outside the lower urinarytract, such as deficits in physical function and/or cognitive function.

A variety of treatment options are currently available to treatincontinence. Some of these treatment options include external devices,behavioral therapy (such as biofeedback, electrical stimulation, orKegal exercises), injectable materials, prosthetic devices and/orsurgery. Depending on age, medical condition, and personal preference,surgical procedures can be used to completely restore continence. Onetype of procedure, found to be an especially successful treatment optionfor SUI in both men and women, is a sling procedure.

A sling procedure is a surgical method involving the placement of asling to stabilize or support the bladder neck or urethra. There are avariety of different sling procedures. Slings used for pubovaginalprocedures differ in the type of material and anchoring methods. In somecases, the sling is placed under the bladder neck and secured viasuspension sutures to a point of attachment (e.g. bone) through anabdominal and/or vaginal incision. Examples of sling procedures aredisclosed in U.S. Pat. Nos. 5,112,344; 5,611,515; 5,842,478; 5,860,425;5,899,909; 6,039,686, 6,042,534 and 6,110,101.

Although serious complications associated with sling procedures areinfrequent, they do occur. Complications include urethral obstruction,development of de novo urge incontinence, hemorrhage, prolonged urinaryretention, infection, and damage to surrounding tissue and slingerosion.

The TVT Tension-free Vaginal Tape procedure utilizes a Prolene™nonabsorbable, polypropylene mesh. The mesh is a substantially flat,rectangular knitted article. The mesh includes a plurality of holes thatare sized to allow tissue ingrowth to help avoid infection. A plasticsheath surrounds the mesh and is used to insert the mesh. During thesling procedure, incisions are made in the abdominal (i.e. suprapubic)area and in the vaginal wall. Two curved, needle-like elements are eachconnected to an end of the vaginal sling mesh. A sling-free end of oneof the needle-like elements is initially pushed through the vaginalincision and into the paraurethral space. Using a handle attached to theneedle, the needle is angulated laterally (for example, to the right) toperforate the endopelvic fascia, guided through the retropubic space andpassed through the abdominal incision. The handle is disconnected andthe needle is then withdrawn through the abdominal wall, therebythreading a portion of the sling through the tissue of the patient. Thehandle is then connected to the other needle and the technique isrepeated on the contralateral side, so that the mesh is looped beneaththe bladder neck or urethra. The sling is positioned to provideappropriate support to the bladder neck or urethra. Typically a Mayoscissors or blunt clamp is placed between the urethra and the sling toensure ample looseness of the sling. When the TVT mesh is properlypositioned, the cross section of the mesh should be substantially flat.In this condition, the edges of the mesh do not significantly damagetissue. The sling ends are then cut at the abdominal wall, the sheath isremoved and all incisions are closed.

Complications associated with the TVT procedure and other known slingprocedures include injury to blood vessels of the pelvic sidewall andabdominal wall, hematomas, urinary retention, and bladder and bowelinjury due to passage of large needles. Further, a separate cystoscopyprocedure is usually required in order to confirm bladder integrity orrecognize a bladder perforation after each insertion of the needle-likeelement. One serious disadvantage of the TVT procedure, particularly forsurgeons unfamiliar with the surgical method, is the lack of informationconcerning the precise location of the needle tip relative to adjacentpelvic anatomy. If the needle tip is allowed to accidentally pass acrossthe surface of any blood vessel, lymphatic duct, nerve, nerve bundle ororgan, serious complications can arise. These shortcomings, attempts toaddress these shortcomings and other problems associated with the TVTprocedure are disclosed in PCT publication nos. PCT WO 00/74613 and PCTWO 00/74594.

Additional problems are associated with the TVT and other slingprocedures. Due to the tough fibrous nature of fascia and muscletissues, forceps or similar instruments are needed to withdraw theneedles through the abdominal wall. However, the smooth surface of theneedles, which facilitates insertion through the tissues, preventssecure attachment of the forceps onto the needles, causing slippage ordetachment of the forceps during the withdrawal procedure. Removal andreuse of the handle of the TVT product is also a cumbersome, timeconsuming process, requiring the surgeon to manually rotate the handleuntil the handle is unscrewed from the needle. Reusing the handlepresents a contamination risk, particularly if the handle and screwthreads are not properly cleaned and sterilized after use on one side ofthe patient.

The problems associated with improper placement of the TVT mesh areparticularly troublesome. If the mesh is too loosely associated with itsintended physiological environment, the mesh may be ineffective insupporting the urethra and treating incontinence. Several complicationscan arise from a mesh that is too tightly placed including retention,sling erosion and other damage to surrounding tissue such as the urethraand vagina.

Once the sheath is removed from the mesh of the TVT product, frictionbetween the mesh and tissue keeps the mesh in position and it becomesvery difficult to subsequently adjust the position of the mesh relativeto tissue. Because the tension of the sling is an important part of thesling procedure, surgeons will nonetheless attempt to adjust the tensionof a sling even after the sheath is removed. TVT mesh is elongate,substantially flat and elastic. When pulled on longitudinally, the TVTmesh deflects elastically. If insufficient adjustment force is applied,the sling will simply exhibit a memory property and return to itsoriginal, unacceptable position. As a result, surgeons are tempted touse a great deal of force in order to loosen a sling that is perceivedto be too tightly associated with its intended physiologicalenvironment. If excessive force is applied, the mesh will plasticallydeform and the cross section of the mesh will become arcuate. Underexcessive deformation, the holes of the TVT mesh become significantlysmaller, and risk deterring tissue ingrowth. Without tissue ingrowth,the potential for infection is believed to increase. In the excessivelydeformed state, the edges of the mesh tend to curl up and present arelatively sharp, frayed surface. In this curled or deformed state, theedges of the TVT mesh present sharp surfaces that can readily abrade orotherwise damage adjacent tissue such as the urethra, bladder or vagina.

Attempts to reposition the TVT sling are likely to fail in two modes.First, the surgeon may apply insufficient elongation force to the mesh(e.g. with forceps), resulting in temporary elastic deformation of themesh followed by a return by the mesh to its original, unacceptableposition after the force is removed. Second, the surgeon may applyexcessive force to the mesh resulting in the curling deformationdescribed above with the attendant risk of tissue damage. Additionally,an axially deformed sling necks down (i.e. decreases in width) andprovides less cross sectional area to support the urethra. Thus, even ifthe edges do not curl, excessive deformation of the TVT sling risksadversely affecting sling performance. In the case of an improperlypositioned sling, some surgeons will cut the TVT mesh and attempt toremove the mesh as reported in the literature.

There is a desire to obtain a minimally invasive yet highly effectivedevice that can be used with minimal to no side effects. Such a deviceshould reduce the complexity of a sling procedure, be biocompatible,adjustable, and non-toxic. The treatment methods using the device shouldreduce pain, operative risks, infections and post operative hospitalstays. Further, the method of treatment should also improve the qualityof life for patients.

BRIEF SUMMARY

In one aspect, the present invention comprises a surgical device fortreating a patient. The surgical instrument is particularly suitable forincontinence procedures. The surgical instrument comprises at least oneneedle; at least one atraumatic dilator having a connection means forconveniently and securely connecting the dilator to the needle during asurgical procedure, and a sling material having a length sufficient forthe sling material to extend from an abdominal wall of the patient tothe urethra of a patient and back to the abdominal wall of a patient,and means for associating the sling with the dilator.

The dilator is sized and shaped to afford atraumatic passage throughbody tissue. Preferably, the dilator is shorter than the needle toreduce the amount of tissue that is deflected at one time. Thiscontributes to the atraumatic nature of the dilator. Preferably, thedilator includes a tapered surface that is shaped to deflect tissue outof the path of the dilator while it is pulled through tissue by theneedle. Also preferably, the dilator includes means for receiving atleast a portion of the end of the sling assembly without increasing theprofile of the dilator.

In another aspect, the present invention comprises a method of treatingurinary incontinence in a patient comprising the steps of creating apathway in tissue that extends between an abdominal wall of the patientto a pubic space of the patient; dilating the pathways; pulling animplantable support material into the pathways while the pathways arebeing dilated; and positioning the implantable support material in atherapeutically effective anatomical position relative to tissue of thepatient that is intended to be supported.

In a preferred embodiment, the method comprises the steps of (a)creating at least one incision in vaginal tissue, (b) creating at leastone suprapubic incision, (c) providing an assembly comprising asynthetic implantable material, and a protective sheath situated aboutthe implantable material, the sheath constructed of a material thataffords visual examination of the implantable material and that affordspassage of the assembly through tissue of the patient, at least oneneedle that is sized, shaped and designed to either i) initially passthe needle from the vaginal incision to the supra pubic incision, or ii)initially pass the needle from the supra pubic incision to the vaginalincision; and means for associating the needle with the assembly, (d)selecting to either initially pass the needle from the vaginal incisionto the supra pubic incision, or to initially pass the needle from thesupra-pubic incision to the vaginal incision; (e) passing the assemblythrough tissue of the patient using the needle according to theselection to locate the implantable material in a therapeuticallyeffective position relative to the urethra of the patient; and (f)removing the protective sheath.

In another preferred embodiment, the invention comprises a method ofimplanting a sling to treat urinary incontinence in a female patientcomprising the steps of: (i) creating at least one incision in vaginaltissue, (ii) creating at least one suprapubic incision, (iii) initiallypassing an end of a curved needle guide through the suprapubic incision,(iv) identifying the posterior portion of the patient's pubic bone withthe end of the needle to controllably move the end of the needle towardthe vaginal incision and to avoid damaging structures such as theurethra and bladder of the patient, (v) passing the end of the needlethrough the vaginal incision, (vi) associating a sling with the needle,and (vii) implanting the sling in a therapeutically effective position.

Preferably, the step of passing the end of the needle through thevaginal incision includes the step of placing the surgeon's fingeradjacent the patient's endopelvic fascia to locate the end of theneedle. Also preferably, the step of associating a sling with the needleincludes the step of securely associating the needle with the sling, andthe step of implanting the sling includes the step of pulling the needlein a direction away from the vaginal incision toward the suprapubicincision while the sling is securely associated with the needle.

In another embodiment, the step of associating the sling with the needleincludes the step of pushing a dilator along the exterior of the needlefrom the vaginal incision toward the suprapubic incision, and the stepof implanting the sling includes the step of having a sling associatedwith the dilator so that passage of the dilator along the needle fromthe vaginal incision toward the suprapubic incision implants the sling.Preferably, the step of associating a sling with the needle occurs afterthe step of passing the end of the needle through the vaginal incision.

Alternatively, the present invention includes a method of treating maleincontinence. The method includes steps for implanting a sling material.

In another aspect, the present invention comprises a sling system foruse in treating a patient comprising at least one needle having opposingends; a sling material adapted to be associated with the at least oneneedle and sized and shaped to extend beneath a patient's urethra up toa patient's abdomen; and a dilator connectable to either of the opposingends of the at least one needle.

In another aspect, the present invention comprises a surgical needle forimplanting a sling of a sling assembly that includes a dilator. Theneedle comprises an elongate arcuate portion that is sized and shaped towithstand forces encountered during a sling implantation procedure; afirst end having attachment means for associating the first end witheither a releasably attachable handle or a dilator of the slingassembly, and a second end having attachment means for associating thesecond end with either a releasably attachable handle or a dilator ofthe sling assembly. Preferably, the attachment means of the first endincludes surfaces adapted to engage with complementary surfaces oneither i) a handle assembly with a releasable, locking feature or ii) aquick, secure connect dilator of the sling assembly.

In another aspect, the present invention comprises a method ofimplanting a sling to treat urinary incontinence in a patient comprisingthe steps of (i) creating at least one incision in vaginal tissue, (ii)creating at least one suprapubic incision, (iii) placing a curved needlewith a removable handle between the vaginal incision and the suprapubicincision, (iv) then removing the handle, (v) then associating a slingwith the needle, and (vi) implanting the sling in a therapeuticallyeffective position. In one embodiment, the step of associating the slingwith the needle includes the step of pushing a dilator along theexterior of the needle. In another embodiment, the step of placing acurved needle with a removable handle between the vaginal incision andthe suprapubic incision, includes the step of initially placing theneedle in the vaginal incision and moving the needle toward thesuprapubic incision. Preferably, the step of placing a curved needlewith a removable handle between the vaginal incision and the suprapubicincision includes the step of initially placing the needle in thesuprapubic incision and moving the needle toward the vaginal incision.

In yet another embodiment, the present invention comprises a slingassembly for use in treating a patient comprising a surgical mesh havinga length sufficient to extend from a pubic space of the patient beneaththe urethra to an abdomen of the patient on either side of a bladder ofthe patient; a dilator for passage through tissue of the patient, thedilator being operatively associated with the surgical mesh; and thedilator including surfaces that are sized and shaped to atraumaticallydeflect tissue during passage of the dilator through tissue. The dilatoris adapted to be pulled through tissue by the needle. Optionally, thesling assembly may include a sheath.

In another aspect, the present invention comprises a surgical kitassembly for treating a patient comprising at least two needles, each ofthe needles sized and shaped to extend substantially between anabdominal wall and a pubic region of a patient; at least two dilatorspermanently attachable to the needles; a length of implantable materialwith a pair of ends, means for associating the ends of the implantablematerial with the dilators; and at least two handles corresponding tothe needles, the handles being releasably attachable to either end ofthe needles. The kit may optionally include a cystoscopic aid.

BRIEF DESCRIPTION OF THE DRAWING

Other features and advantages of the present invention will be seen asthe following description of particular embodiments progresses inconjunction with the drawings, in which:

FIG. 1 is a side view of a sling according to one aspect of the presentinvention;

FIG. 1A is a top view of a sling according to another aspect of thepresent invention;

FIG. 2 is a schematic view of the female urinary system;

FIG. 3 is a schematic view of the male urinary system;

FIG. 4 is a perspective view of one embodiment of the sling deliverysystem of the present invention, showing the sling delivery systemdisassembled;

FIG. 5 is a perspective view of one embodiment of a sling assembly ofthe present invention;

FIG. 6 is an end view showing a vaginal incision and a sling properlylocated according to an aspect of the present invention;

FIG. 7 is a side perspective view of one embodiment of the implantedsling of the present invention;

FIG. 8A is a top view of sling showing a side of the sling that ispreferably placed facing the urethra;

FIG. 8B is a top view of the sling of FIG. 8A, showing the side of thesling opposite the side of the sling shown in FIG. 8A, which side ispreferably positioned opposite the urethra;

FIG. 9A is a perspective view of an embodiment of sheath according tothe present invention;

FIG. 9B is a bottom view of a sheath and sling assembly according to thepresent invention after slight removal of the sheath;

FIG. 10A is a perspective view of a dilator according to an aspect ofthe present invention;

FIG. 10B is a top view of the dilator of FIG. 10A;

FIG. 10C is a side view of the dilator of FIG. 10A;

FIG. 10D is a sectional view of the dilator of FIG. 10A;

FIG. 10E is a side view showing a dilator assembled to either a sheathor sling according to aspects of the present invention;

FIG. 11 is a side view of an embodiment of needle, handle and slidablehandle according to an aspect of the present invention;

FIG. 12A is a perspective view of another embodiment of the dilator ofthe present invention and portions of a sling assembly or sling in adisassembled condition;

FIG. 12B is a perspective view showing the dilator of FIG. 12A and aninsertion needle in a disassembled condition;

FIG. 13 is a side view of another embodiment of the dilator of thepresent invention and portions of a sling or sling assembly, showing thedilator in an unassembled condition;

FIG. 14A is a perspective view of another embodiment of adilator/cystoscopy aid of the present invention;

FIG. 14B is a sectional view of the dilator/cystoscopic aid of FIG. 14A;

FIG. 14C is a side view of a cystoscopic aid/dilator attached to a slingassembly according to the present invention;

FIG. 15A is a side view of another embodiment of dilator according toanother aspect of the present invention;

FIG. 15B is a perspective view of the dilator of FIG. 15A showing thedilator attached to a sling or sling assembly;

FIG. 16A is a side view of a needle of the present invention;

FIG. 16B is a side view of a portion of an embodiment of needleaccording to the present invention;

FIG. 16C is a sectional view of a needle according to the presentinvention; taken approximately along the lines of 16C—16C in FIG. 16B;

FIG. 16D is a perspective view of an end portion of a needle accordingto an aspect of the present invention;

FIG. 16E is an end view of a needle in an unseated position;

FIG. 16F is an end view of a needle in a seated position;

FIG. 17A is a perspective view of another embodiment of the needle ofthe present invention;

FIG. 17B is a perspective view of another embodiment of needle accordingto the present invention;

FIGS. 18A-18E illustrate one embodiment of the handle of the presentinvention, wherein:

FIG. 18A is a perspective view of the handle;

FIG. 18B is a sectional view of the handle, showing elements in adisassembled condition;

FIG. 18C is a sectional view of the handle of FIG. 18A;

FIG. 18D is a sectional view of the handle of FIG. 18A showing elementsin a locked position;

FIG. 18E is a perspective view of the handle of FIG. 18A showingelements in an unlocked position;

FIG. 19A is a perspective view of another embodiment of the handle ofthe present invention, showing two handles and portions of matingneedles,

FIG. 19B is a perspective view of another embodiment of handle accordingto the present invention;

FIG. 19C is a perspective view of another embodiment of handle accordingto the present invention;

FIG. 20A is a perspective view of another handle according to thepresent invention;

FIG. 20B is a sectional view of the handle of FIG. 20A;

FIG. 20C is an end view of the handle of FIG. 20A;

FIG. 21A is a side view of another embodiment of the handle of thepresent invention;

FIG. 21B is another side view of another embodiment of handle accordingto the present invention;

FIG. 22A is a side schematic illustration of one embodiment of aslidable handle and locking mechanism of the present invention;

FIG. 22B is a schematic illustration of the slidable handle of FIG. 22A;

FIG. 23A is a schematic perspective view of another embodiment ofslidable handle and locking mechanism of the present invention;

FIG. 23B is a schematic view of portions of the slidable handle andlocking mechanism of FIG. 23A;

FIG. 23C is a perspective view of a portion of the handle of FIG. 23A;

FIG. 24A is a perspective view of another embodiment of a slidablehandle and locking mechanism of the present invention;

FIG. 24B is a schematic perspective view of portions of the handleintroduced in FIG. 24A;

FIG. 24C is a sectional view of elements of another handle according tothe present invention;

FIG. 24D is a sectional view of elements of another handle according tothe present invention;

FIG. 24E is a sectional view of elements of another handle according tothe present invention;

FIG. 25 is a schematic perspective view of elements of another handleaccording to the present invention;

FIG. 26 is a sectional view of another embodiment of a slidable handleand locking mechanism of the present invention;

FIG. 27 is a perspective view of another embodiment of a lockingmechanism of a slidable handle of the present invention;

FIG. 28 is a perspective view of elements of another embodiment oflocking mechanism of a slidable handle of the present invention;

FIGS. 29A through 29D are perspective views sequentially showing theinsertion of a needle suprapubically according to one aspect of thepresent invention, wherein:

FIG. 29A shows the needle just passing an abdominal incision;

FIG. 29B illustrates the needle as the surgeon seeks to identify thetactile feel of the resistance provided in part by the posterior portionof the pubic bone;

FIG. 29C shows the needle as it passes along the posterior surface ofthe pubic bone which may be used as an anatomical guide for a surgeon asthe needle approaches a vaginal incision;

FIG. 29D illustrates the needle as it passes out of a vaginal incision;

FIG. 30A is a schematic end view generally illustrating regions to avoidand preferred regions for needle passage in a patient according to anaspect of one embodiment of the present invention;

FIG. 30B is a schematic end view showing two needles placed in a patientand ready to receive a sling assembly according to another aspect of thepresent invention;

FIG. 30C is a perspective view of a sling system attached to two needlesaccording to a preferred embodiment of the present invention;

FIG. 31A is a perspective view of the sling placed in proximity to theurethra of a patient that shows one method of changing the position ofthe sling during the surgical procedure, which method is a method ofloosening the tension of the sling;

FIG. 31B is a perspective view of another method of adjusting thetension of the sling during the surgical procedure according to thepresent invention, showing a method of tightening the tension of thesling;

FIG. 31C is a perspective view the sling according to the presentinvention after the dilators have been separated from the rest of theassembly, but prior to final trimming;

FIG. 32 is a perspective view of the sling according to the presentinvention after the sheath has been removed and the sling has beentrimmed;

FIG. 33 a schematic perspective view of another embodiment of the methodof use of the sling delivery system of the present invention withrespect to the male anatomy;

FIG. 34 is a perspective view of another embodiment of surgicalprocedure according to the present invention showing a needle beinginitially inserted into the body transvaginally as opposed tosuprapubically;

FIG. 35 is an end view of two surgical needles after being inserted inthe body transvaginally as shown in FIG. 34, showing handles of theneedles on one end of the needles with dashed lines and using an arrowand solid lines to show that the handles are removed and reattached tothe needles on the other ends of the needles,

FIG. 36 is a perspective view of the needles of FIG. 35 after a slingassembly has been attached;

FIG. 37 is a perspective view of another method of adjusting the tensionof the sling, showing a method of loosening the tension of the slingeither during or even after the surgical procedure;

FIG. 38 is a schematic view of a cadaver;

FIG. 39 is a perspective view of the cadaver of FIG. 38 showing properplacement of a prior art needle that was initially insertedtransvaginally (on the left) and showing proper placement of a needleaccording to the present invention that was initially insertedsuprapubically (on the right);

FIG. 40 is a perspective view of a cadaver showing undesirable lateraldeviation of the prior art needle that was initially insertedtransvaginally (on the left) and showing undesirable lateral deviationof the needle according to the present invention that was initiallyinserted suprapubically (on the right); and

FIG. 41 is a top view of an alternative sling embodiment according tothe present invention.

DETAILED DESCRIPTION

The following description is meant to be illustrative only and notlimiting. Other embodiments of this invention will be apparent to thoseof ordinary skill in the art in view of this description.

Referring to FIG. 4, an embodiment of assembly 40 in accordance with thepresent invention includes a sling assembly 46 that includes a sling 42for treating incontinence. The present invention is particularlysuitable for treating stress urinary incontinence (SUI) diagnosed withurethral hypermobility or intrinsic sphincter deficiency in both men andwomen. Although the invention as disclosed herein generally refers toSUI, treatment of other urological disorders, such as urge incontinence,mixed incontinence, overflow incontinence, functional incontinence,prolapse (e.g. vaginal), enteroceles (e.g. of the uterus), rectocelesand other non-urological disorders, are also included within the scopeof the present invention. It is contemplated that the present inventionmay also be utilized in conjunction with other procedures, such as, butnot limited to, procedures for addressing cystocele prolapse, vaginalprolapse and anatomic hypermobility.

The sling assembly 46 preferably includes an implantable member (e.g. ahammock, sling or strip) 42 within a protective sheath 44. The sheath 44is used during insertion of the strip 42. After the sling 42 isimplanted, the sheath 44 is removed and discarded.

Each of the two ends 48, 50 of the elongate sling assembly 46 attachesto a first end 52 of a dilator 54 or needle-sling connector. The dilator54 dilates a needle track for ease of sling introduction and positioningwithin the patient. A second end 56 of each dilator 54 is sized andshaped to quickly and securely connect to a first end 58 of a slim,arc-shaped needle 60. An adjustable handle 64 is preferably removablyand repositionably attached to a second end 62 of the needle 60. Eachend 58, 62 of the needle 60 is preferably keyed to allow for convenient,secure attachment of the needle 60 relative to the handle 64 and dilator54. In a preferred embodiment, the key feature prevents rotation of thedilator 54 relative to the needle 60. Alternatively, the handle 64 maybe rigidly affixed to the needle 60.

Referring to FIGS. 1 and 1A, the sling 42 preferably comprises first andsecond major surfaces, a pair of end portions I, and a support portionII for placement in a therapeutically effective position relative to aphysiological environment intended to be supported (e.g. near theurethra). In one aspect of the present invention, the sling 42preferably has a tension adjustment or control member 66 associated withthe sling 42, for transferring sling adjustment forces from one portionof the sling 42 to other portions of the sling 42 such as the ends 61 ofa support portion II of the sling (see FIGS. 1 and 1A). The member 66affords effective repositioning of the sling 42 while avoidingundesirable permanent deformation of the sling 42. In the embodiment ofthe present invention depicted in FIGS. 1 and 1A, the tension adjustmentmember is a filamentary member. The tension adjustment member 66 ispreferably threaded along the length of sling 42. More preferably, thetension adjustment member 66 is connected at some points. For example,if the sling 42 comprises a synthetic mesh material, then the filamentmay be affixed at the junctures 61 between the support portion II andthe end portions I.

The sling 42 is preferably at least substantially surrounded by theprotective sheath 44, as shown in FIGS. 4 and 5. The sling 42, tensioncontrol element 66 and sheath 44 are made of biocompatible materialshaving sufficient strength and structural integrity to withstand thevarious forces exerted upon these components during an implant procedureand/or following implantation within a patient. Preferably, theprotective sheath 44 is constructed of a material that affords visualexamination of the implantable sling material 42 and that affordsconvenient passage of the assembly 46 through tissue of the patient.

Preferably, the overall dimensions of the sling assembly 46, includingindividual sheath 44, sling 42 and tension control member 66, aresufficient to extend from an abdominal incision, to an undersurface ofthe urethra and back to another abdominal incision with additional sizeto account for the imprecision associated with the range of humananatomy sizes. In a preferred embodiment, the sheath length L of thedevice 40 of the present invention is approximately within the range of52.0 cm to 58.5 cm (20.5 inches to 23.0 inches), sheath width W isapproximately within the range of 1.0 cm to 1.63 cm (0.482 inch to 0.642inch) and sheath material thickness is approximately within the range of0.127 mm to 0.203 mm (0.005 inch to 0.008 inch), respectively. Theassociated sling 42 has a length X, width Y and thickness approximatelywithin the range of 49 cm to 51 cm (19.3 inches to 20.1 inches), 1.0 cmto 1.2 cm (0.394 inch to 0.472 inch) and 0.508 mm to 0.711 mm (0.020inch to 0.028 inch), respectively. In addition, the length of thetension control element 66 should be approximately equivalent to orslightly longer than the length of the sling 42 to tighten or loosen thesling 42 after it is placed in the body. Alternative lengths, widths andthicknesses can also be used.

As used herein, the term “sling” is used generally to include a widevariety of shapes and sizes, materials and treatments. While the sling42 is preferably rectangular for treating SUI in females, other shapesare also contemplated. Depending on the treatment addressed (e.g. toprovide hammock support for the bladder or bladder neck, or to address arectocele, enterocele or prolapse) the sling may be any of a widevariety of shapes. As an example, the sling may be of the general shapeof the slings described and shown in Moir et al., The Gauze-HammockOperation, Journal of Obstetrics and Gynaecology of the BritishCommonwealth, Volume 75, No. 1, Pps. 1-9 (1968). FIG. 41 illustratesanother example of a shape of a sling 42G according to the presentinvention. This sling shape is believed to be useful for providing ahammock support for an anatomical structure such as the bladder or thejuncture between the bladder and bladder neck.

In one embodiment, the sling 42 is made of a mesh material. The meshmaterial comprises one or more woven or inter-linked filaments or fibersthat form multiple fiber junctions throughout the mesh. The fiberjunctions may be formed via weaving, bonding, ultrasonic welding orother junction forming techniques, including combinations thereof. Inaddition, the size of the resultant openings or pores of the mesh shouldbe sufficient to allow tissue in-growth and fixation within surroundingtissue. As an example, not intended to be limiting, the holes maycomprise polygonal shaped holes with diagonals of 0.132 inches and 0.076inches. The quantity and type of fiber junctions, fiber weave, pattern,and material type influence various sling properties or characteristics.Non-mesh sling configurations are also included within the scope of theinvention. As another example, not intended to be limiting, the mesh maybe woven polypropylene monofilament, knitted with a warp tricot. Thestitch count may be 27.5 courses/inch (+or −2 courses) and 13 wales/inch(+or −2 wales). The thickness of this example is 0.024 inches.

In a preferred embodiment, the mesh material of the sling 42 comprises aflexible, polypropylene monofilament that resists weakening ordegradation when implanted within a patient. One such material isMarlex™ material. Other mesh and non-mesh materials including, but notlimited to, synthetic biomaterials, allografts, homografts,heterografts, autologous tissues, materials disclosed in U.S.Provisional Applications S/No. 60/263,472, S/No. 60/281,350 and S/No.60/295,068, whose contents are fully incorporated herein by reference,synthetic materials (such as metallics, polymerics, and plastics) andany combination of such materials may also be used with the device ofthe present invention. Specific examples of synthetic sling materialsinclude, but are not limited to polypropylene, polyethylene, nylon, PLLAand PGA. Preferably, the sling material should cause minimal to noreaction with body tissues and fluids and indefinitely retain itsparticular material characteristics/properties. Further, portions or allof the sling 42 may be configured or fabricated from a material toeither promote or prevent tissue in-growth, or are resorbable toaccomplish the desired purpose.

In another embodiment of the invention, the sling 42, sling assembly 46or portions thereof, may have one or more substances associatedtherewith through a process such coating. Examples of appropriatesubstances include, without limitation, drugs, hormones, antibiotics,antimicrobial substances, dyes, silicone elastomers, polyurethanes,radiopaque filaments or substances, anti-bacterial substances, chemicalsor agents, including any combinations thereof. The substances may beused to enhance treatment effects, reduce potential sling rejection bythe body, enhance visualization, indicate proper sling orientation,resist infection or other effects. For example, a dye may be coated onone surface of the sling 42. The dye provides the practitioner/surgeonwith a visual indicator to aid in properly orienting the sling 42 at thetarget site within the patient and to avoid undesirable twists along thelength of the sling 42. As another example, the sling may be coated bythe process described in U.S. Pat. Nos. 5,624,704; 5,756,145; 5,853,745;5,902,283 and 6,162,487 (the entire contents of which are herebyincorporated by reference).

The sling 42 of the present invention need not have additional suturesor other anchoring devices. Upon implantation, a portion of the sling 42is passed and/or woven through various layers of abdominal/pelvictissue. The frictional forces created between the sling 42 and patienttissue prevents movement and loss of tension once the sling 42 isproperly located at the target site within the lower abdominal area ofthe patient. As a result, the sling 42 remains securely in place, evenwhen subjected to various increased abdominal pressures.

The sling 42 is designed to remain within the body of a patient as animplant for a predetermined therapeutically effective amount of time.The sling may be non-absorbable, absorbable or resorbable, including anycombinations of these material properties, depending on the desiredtreatment. For example, portions of the sling 42 or sling assembly 46may be constructed of a bioabsorbable material designed to last for apredetermined period of time within the patient, that should besufficiently long to afford treatment of the patient's need. The generalcharacteristics of the sling material and design should be such as towithstand the various forces exerted upon it during implantation (forexample, frictional forces associated with tissue resistance) and afterimplantation (for example, increased abdominal or bladder pressurecaused by coughing, laughing, sneezing, or lifting). Preferably, thesling 42 is configured to exploit the healing process and providesadequate support to correct incontinence.

The sling assembly 46 preferably has a feature that assists the surgeonin placing the sling 42 in a therapeutically effective anatomicalposition. The precise, final location of the sling 42 will depend on avariety of factors including the particular surgical procedure(s)performed, and any preconditions of the patient such as scar tissue orprevious surgeries. For example, it may be preferred to place the sling42 in close proximity to, but not in contact with, a mid portion of theurethra 16 to treat incontinence. In a male patient, the sling 42 may beplaced proximate, but not in contact with the bulbar urethra.

Several different embodiments of tension adjustment member are withinthe scope of the present invention. Referring to the embodiment shown inFIG. 7, a mesh sling 42 is shown. A tension adjustment member 66 iswoven into the sling and attached to the sling 42 via two attachmentpoints 78 located near the midsection 80 of the sling 42 and alsocorresponding to locations near each side of the urethra 16.

Other attachment configurations for member 66 are also included withinthe scope of the claimed invention. The tension adjustment member 66 maybe a separate element (e.g. threaded along the length of the sling 42)or it may be an integral part of the sling matrix. The tensionadjustment means may comprise one filament threaded along the mesh.Alternatively, more than one filament may be used. The tensionadjustment member 66 shown in FIGS. 1 and 1A is attached to the mesh atthe ends of the middle portion II. Alternatively, the tension adjustmentmeans may comprise at least one filament that is integrally woven in themesh and that has extension properties that are different than the otherfilaments that form the mesh.

The tension adjustment means may be threaded axially along the slingmesh, through the middle of the sling or adjacent its ends. Preferably,this is done at the time of manufacture to provide an assembly that isconveniently used during a surgical procedure, without requiring thesurgeon to assemble the sling and tension adjustment means during asurgical procedure. In one embodiment, the tension adjustment means 66may comprise a plurality non-parallel. For example, the elements maycross in the support portion II. As of elements woven axially along thesling. The plurality of elements may be another example, the tensionadjustment means may comprise a portion of the support portion that ismore tightly woven than another portion of the support portion.

Preferably, the tension adjustment member is a continuous, uninterruptedmember, as opposed to a member in separate pieces. A continuous,uninterrupted member allows the sling to be tightened and loosened andprovides a plurality of locations that can be grasped along the sling 42to modify the tension of the sling. Also preferably, the member extendsthe entire length of the sling, from one end to the other. A continuous,uninterrupted member allows the entire sling to be repositioned asopposed to merely isolated portions of the sling.

The tension adjustment member 66 may comprise a monofilament element ora braided member. The tension adjustment member 66 may be constructedfrom a biodegradable material or a non-biodegradable material orcombinations thereof. The monofilament may be round, flat or othershapes to aid in fixation or identification.

The position adjustment member 66 enables surgeons to easily tighten orloosen the sling tension during the surgical procedure, even after thesurgeon removes the sheath 44. To reduce the tension of the sling 42using the position adjustment member 66, the surgeon contacts the sling42 and position adjustment member 66 adjacent the urethra and pulls awayfrom the urethra. The tension of the sling may be increased by graspingthe sling 42 and position adjustment member 66 above the abdominalincision and pulling upward. One or both ends of the sling 42 andposition adjustment member 66 may be grasped to increase the tension ofthe sling 42. Affording adjustment of the sling 42 position afterremoval of the sheath 44 facilitates proper sling placement and helpsavoid complications such as retention and sling erosion arising out ofimproper sling placement.

The various configurations, properties or characteristics of theposition adjustment member 66 may vary or remain constant along thelength of the position adjustment member 66. For example, the positionadjustment member 66 may be made of a variety of materials including,but not limited to, Prolene™, nylon, polypropylene, Deklene™,poly-L-lactide (PLLA), polyethylene glycol (PGA), polyester and anycombination of materials. Depending on the desired treatment, the member66 or portions thereof, may be absorbable, non-absorbable and/orresorbable. If the member 66 is constructed from an absorbable,bioabsorbable or bioresorbable material or the like, then the member 66may be optionally left in the sling 42 after the surgical procedure.This offers the advantage of affording the use of the tension adjustmentmember 66 in a minimally or non-invasive near term, post operation slingtension adjustment procedure.

FIG. 37 illustrates an example of a post operative sling tensionadjustment procedure. For example, the patient may be experiencingslight retention shortly after the surgical procedure and the surgeonmay wish to slightly loosen the sling 42. While the surgeon may make aslight dissection in the vagina 20 to reach the member 66, the surgeonmay also have the option of placing a blunt instrument 382 into theurethra 16 and slightly deflecting the urethra to thereby loosen thetension of the sling in a lasting fashion. In contrast, if this stepwere attempted with prior art slings, the elastic nature of such slingswould likely result in temporary, elastic deformation of the slingwithout a lasting change in the position of the sling. The prior artprocedure also risks loss of sling functionality as previouslydescribed.

The individual fibers or filaments comprising the tension adjustmentmember 66 may be extruded, woven, braided, spun, knitted, non-woven orhave other similar configurations. Member 66 properties, such as tensilestrength, elongation at break point, stiffness, surface finish, etc.,may be similar to or different from those of the sling 42 and may varyalong the length of the member 66.

In one embodiment, the tension adjustment member 66 may be secured tothe assembly 40 by attaching one or more ends of the tension adjustmentmember 66 to the sheath 44. In another embodiment, the tensionadjustment member 66 is secured to the device 40 simply by interlacingor weaving the tension adjustment member 66 at predetermined pointsalong the length of the sling 42. In yet another embodiment, the tensionadjustment member 66 may include one or more points of attachment alongthe length of the sling 42. The tension adjustment member 66 may beattached to the sling assembly 46 via knotting, weaving, bonding,ultrasonic welding or other attachment techniques, includingcombinations thereof, to prevent tension adjustment member 66 detachmentduring and/or following sling implantation.

Preferably, the tension adjustment member 66 is knotted at preselectedlocations along the length of the sling 42 without any additionalelements added to the assembly to connect the member 66 to the sling 42.Knotting allows attachment of the member 66 to the sling 42 withoutadditional securement structure. This embodiment avoids contact betweensuch additional retaining structure and tissue and any attendantcomplications. The knot may comprise a single throw, half hitch knot,square knot; single overhand knot, a slipknot or a heat formed knot.Optionally, a loop or other shape may be formed in the member 66adjacent the end 61 of the support portion II to afford convenience inidentifying the end 61 of the support portion II. Such a loop or othershape may be conveniently located and cut should it be desired to removethe portion of the member 66 associated with the support portion II.

It is noted that, in an embodiment with a continuous length positionadjustment member 66 that is anchored at a plurality of locations 61 (asshown in FIGS. 1 and 1A), when a user grasps a mid portion II of thesling 42 and member 66 and pulls, some of the pulling force isdistributed or transmitted from the grasped location to a plurality ofattachment points 61. This is believed to assist in providing a slingthat is more effectively repositioned in a permanent fashion.

The means 66 for adjusting the tension or anatomical location of thesling 42 may optionally comprise a means for indicating properorientation of the sling 42. Referring to FIG. 1, the tension adjustmentelement 66 is woven along the length of the sling 42. In the supportportion II of the sling 42, the tension adjustment element 66 is wovenmore frequently 67 than the less frequent weave 69 of the element 66 inthe end portions I of the sling 42. Additionally, as shown in FIGS. 1and 1A, a majority of the element 66 is woven above one major sidesurface of the sling 42 in the support portion. As shown in FIG. 6, themajor side of the sling with the majority of protruding tensionadjustment means 66A is located opposite the urethra. If the material ofthe element 66A is constructed of a different color, shape or sizerelative to the material of the sling 42A, the surgeon may more readilyvisualize proper placement of the sling 42A.

Referring to the embodiment of the invention shown in FIGS. 8A and 8B,the tension adjustment member 66 is woven approximately along thecenterline or axial length of the sling 42. In one embodiment, the weavepattern of the tension adjustment member 66 is used as an indicator ofproper sling orientation after implantation. For example, the weavepattern on a first major side surface 82 of the sling 42, shown in FIG.8A, has small segments or loops of exposed member 66. The second majorside surface 84 (i.e. opposite side 82 or reverse side) of the sling 42,shown in FIG. 8B, has larger segments or loops of exposed tensionadjustment member 66. Upon implantation of the sling 42, the firstsurface 82 of the sling 42, having minimal lengths of filament segmentsor loops protruding above the material of the sling 42, is preferablypositioned to face the urethra 16 of the patient. It is preferred thatthis first surface 82 of the sling 42 face the urethra 16 to minimizefilament 66-urethra contact, particularly during adjustment of the sling42, and to assist the surgeon in identifying the location of the member66.

In another embodiment of the invention, one or more substances may beassociated with the member 66 by, for example, a coating process. Thecoatings may be selected from the same group mentioned above withrespect to coatings for the sling 42. The substances may be used toenhance treatment effects, indicate proper sling orientation, enhancetension adjustment member visibility, and resist infection or othereffects. For example, the tension adjustment member 66 may be dyed acontrasting color (e.g. blue) with respect to the sling color (e.g.white). The contrasting color of the tension adjustment member 66provides the surgeon with a visual indicator that can be used to confirmproper sling orientation. In addition to coating substances, othercomponents including, without limitation, tags, labels or indicia mayalso be used to indicate proper sling orientation or enhance tensionadjustment member 66 visibility/identification.

FIG. 6 illustrates a sling 42A in a proper position. The surgeon maylook through the vaginal incision and view substantially all of theposition adjustment member 66A protruding above a support II (see FIG.1A) or middle portion of the sling 42A when the sling 42A is properlyplaced. If only a minor portion of the position adjustment member 66A isvisible protruding above a major surface of the sling 42A, then thesling is misplaced and corrective action should be taken. Once the sling42A is located in its final position, the portion of the positionadjustment member 66A in the support portion II of the sling (see FIG.1A) may optionally be cut or released at the ends 61 of the supportportion II and removed prior to closing the vaginal incision.Optionally, the sling 42A may include a means for conveniently locatingand cutting the tension member 66A at this point to assist in removal ofthat portion of the tension member 66. As described above, that meansmay comprise a loop or other shape in the tension member 66.Alternatively, but not preferably, a structure attached to the positionadjustment member 66 my be used to facilitate visualization,maneuverability and cutting of the position adjustment member 66.

Also optionally, the sling 42A may include a means for grasping thesling 42A and/or the tension member 66A in the support portion II of thesling. For example, the means may comprise a small handle 15 attached tothe tension member 66 in the support portion II of the sling 42A.

Referring to FIGS. 4 and 5, the sling 42 and tension adjustment member66 may be at least partially housed within a sheath 44. Preferably, thesheath 44 is made of a relatively transparent and flexible materialhaving a smooth outer surface. The transparency of the sheath 44 enablesa manufacturer or user of the device 40 to view the sling and tensionadjustment member 66 encased within the sheath 44 and visually determinewhether the sling 42 assembly contains any defects, such as a twistedsling, detached tension adjustment member 66, torn sling fibers or otherrelated flaws, as well as orientation within the sheath. In addition,the sheath provides a protective covering for the sling 42 and tensionadjustment member 66 which also resists bacterial and viralcontamination of these components.

In a preferred embodiment, the sheath 44 is made of polyethylene. Othermaterials including, without limitation, polypropylene, nylon, polyesteror Teflon may also be used to fabricate the sheath 44. The sheathmaterial should be flexible and provide sufficient structural integrityto withstand the various forces exerted on the sheath 44 throughout thesling delivery procedure. In general, the sheath 44 is configured tohave sufficient flexibility to facilitate user manipulation and adequatestructural strength to withstand the various forces applied to thesheath 44 during delivery and/or positioning of the sling assembly 46.It should also conveniently separate from the sling material 42 afterthe sling 42 is implanted without materially changing the position ofthe sling 42.

As shown in FIG. 9A, the sheath 44 preferably comprises two elongatesections 86, portions of which detachably and telescopically overlapnear the middle portion 80 of the sling (not shown). In a preferredembodiment, the length S of the overlapping section is approximately 3.8cm (1.5 inch). However, alternative lengths may also be used. The lengthis preferably sufficient to resist exposure of most of the sling 42 andtension adjustment member 66 prior to sheath 44 removal. In addition toresisting sling exposure, the overlapping section may also be used as avisual indicator for the practitioner or user of the device. Inparticular, positioning the overlapping portion of the sheath 44 underthe bladder neck or urethra 16 ensures proper sling placement (e.g.symmetrical sling placement) and tension within the patient.Additionally, orientation indicia (not shown) may be placed on theoverlapping portion to indicate proper orientation of the sling relativeto the urethra 16.

Alternatively, other configurations of the sheath 44 are within thescope of the present invention. In particular, the sheath may be unitaryas opposed to telescoping with perforations, holes, scores or tear linesdesigned to allow separation and removal of the sheath 44.

During sheath removal, the first section 86 and the second section 86 ofthe sheath 44 are slid off the sling 42 by pulling each end of thesheath 44 away from the middle portion 80 of the sling assembly 46 (asshown by reference directional arrows in FIG. 9B). Removal of the sheath44 causes separation of the overlapping sheath sections, therebyexposing the sling 42 and tension adjustment member 66. In addition, thesmooth outer surface of the sheath 44 provides a relatively frictionlesssurface to facilitate passage of the sheath 44 through the varioustissues. The relatively frictionless motion also avoids disturbing theposition of the sling 42 relative to the anatomy of the patient.

In another embodiment of the invention, the sheath 44, or a portionthereof, is associated with one or more substances including thosesubstances identified with respect to the member 66 and sling 42. Thesubstances may be used to enhance sheath removal, identify twists alongthe sheath 44 (and thereby indicate proper sling orientation), indicatecutting/separation points, indicate center-point, resist infection orprovide other desirable effects. For example, a first surface of thesheath 44 may include a colored stripe that should lie opposite theurethra 16 or bladder neck to ensure proper sling orientation. Thus, thestripe provides the practitioner/surgeon with a visual indicator to aidin properly orienting the sling assembly 46, and ultimately the sling42, within the patient.

The ends of the sheath are preferably connected to a dilator.Alternatively, the sheath may be connected to the sling, and the slingcan be associated with the dilator. The number of dilators will dependon factors such as the shape of the sling. For example, the sling 42Pshown in FIG. 41 includes four dilators 54P.

At least two dilators are preferred. The sling 42 shown in FIG. 4includes two dilators. The first end 48 and second end 50 of the sheath44 are preferably configured for attachment to a dilator 54.

The dilator 54 is a component that atraumatically creates and/or expandsthe passageway through the tissues for sling assembly delivery. Thedilator 54 includes a means for associating with a needle 60. Thedilator 60 is preferably short relative to a needle 60 for ease ofpassage of the assembly and to reduce the overall amount of tissue thatis deflected at one time. Preferably, the dilator is less than 2.5inches in length, and more preferably, it is less than one inch inlength. The maximum radius of a dilator 54 is preferably less than 10mm, more preferably less than 7.5 mm, even more preferably less than 5mm. The tip of the dilator 54 is preferably blunt, as, in preferredembodiments, the leading tip of the dilator 54 will pass through tissuethat has already been pierced by a needle 60.

The dilator 54 may be made from a variety of biocompatible andsterilizable materials including, without limitation, acetal, Delrin®,Acrylonitrile-Butadiene-Styrene (ABS), polyethylene, nylon and anycombination of materials. Alternatively, the sheath 44 may beadditionally or solely connected to an end portion of the sling 42.

The dilator 54 preferably includes means for associating with a surgicalneedle 60. In a preferred embodiment, the association means affords apermanent affixation between the dilator 54 and the needle 60. By“permanent affixation”, it is meant that it would be very difficult tomanually separate the dilator from the needle after they have becomepermanently affixed. After implantation of the sling 42, to separate thesling 42 from the dilator 54/needle 60, the surgeon cuts an end of thesling 42 as described more fully below. The association means preferablyaffords quick and convenient attachment of the dilator 54 to the needle60 to avoid wasting time in the midst of a surgical procedure. Theattachment should also be secure to avoid separation of the needle 60and dilator 54 while the combination is passed through tissue.

The dilator 54 also includes a means for association with the sling 42and/or the sheath 44. For example, the dilator 54 may be preattached tothe sling 42 and/or sheath 44, particularly if the sling is a syntheticmaterial. Alternatively, the dilator may include means for convenientlyattaching to a sling material (e.g. cadaveric or autologous slingmaterial) just prior to sling placement.

Referring to the embodiment of FIGS. 10A-10E, the dilator 54 may beapproximately 3.1 cm (1.2 inches) in length. The dilator 54 preferablyincludes a gentle taper 88 near its second end 56. The dilator is sizedand shaped to provide atraumatic passage through body tissue. The taper88 and relatively smooth outer surface of the dilator 54 facilitateatraumatic passage of the dilator 54 and attached sling assembly 46through the various tissues of the patient. The presence of the dilator54 allows a gentle transition between the diameter of the needle, to theshape of the dilator, and finally to the sling assembly 46, as opposedto prior art assemblies, where the structure of the sling assemblyabruptly increases the profile of the needle and thereby the size of thestructure that must pass through tissue.

Preferably, the first end 52 of the dilator 54 attaches to one end ofthe sling 42, or sheath 44 or sling assembly 46 (shown in FIG. 10E) andthe second end 56 of the dilator 54 may be quickly attached or assembledto a needle 60 (not shown). The sheath 44 is preferably attached to thedilator 54 via a first opening or through-hole 90 located near the firstend of the dilator 54. In this embodiment, the opening 90 operates as auniversal sling material or assembly attachment point which can receivea variety of materials, such as fascia, autologous materials,synthetics, biologic tissues and any other similar tissues, includingany combinations. The edge portion 91 of one end of the sheath 44 isthreaded through the opening 90 of the dilator 54 and secured to thesheath 44, thereby forming a loop 92. The edge portion 91 may befastened onto the sheath 44 via ultrasonic welding, bonding, melting,suturing, sealing or other attachment techniques. Further, as shown inFIGS. 10A and 10B, the first end 52 of the dilator 54 includes acut-away section 94 to provide room to receive sling assembly materialto reduce the overall profile of the sling assembly experienced bytissue during sling passage. Therefore, when the sheath is attached tothe cut-away section, the additional sheath material is not apt tosignificantly increase the relative thickness, diameter or profile ofthe dilator 54.

Alternatively, for dilators 54 manufactured via molding techniques, theend of the sheath 44 may be encased within and secured to the first end52 of the dilator 54 during the molding process. In yet anotherembodiment, the end of the sheath 44 may be fixedly attached within alongitudinal slot located near the first end 52 of the dilator 44 usingan adhesive, ultrasonic welding or other attachment techniques.

Referring to FIGS. 10A-10D, the second end 56 of the dilator 54 includesa second opening or through-hole 96 that extends substantiallyinternally along the longitudinal axis of the dilator 54. The secondopening 96 has an internal diameter generally configured for convenientattachment to a needle 60 or similar sling-delivery device. In oneembodiment, the internal diameter of the second opening 96 of thedilator 54 is approximately within the range of 0.239 cm to 0.318 cm(0.094 inch to 0.125 inch). A shoulder 98 located on the surface 100 ofthe second opening 96 of the dilator 54 and a complementary matingrecess located on the surface of the first end of the needle 60 (seeFIG. 4) securely and permanently attach or lock the dilator 54 andneedle 60 together. Once the needle 60 is inserted into the dilator 54,they are preferably not separated thereafter. After the sling 42 isimplanted, the connected needle 60 and dilator 54 are removed from thesling by cutting an end of the sling as described in greater detailbelow. Preferable, the needle 60 and dilator 54 are disposed.

One or more longitudinal slots 102 located on the outer surface of thedilator 54 and in communication with the second opening 96 allow thewall of the dilator 54 to expand in a radially outward direction whenthe first end of the needle 60 is inserted into the second opening 96 ofthe dilator 54. When the shoulder 98 of the dilator 54 passes the recessof the needle 60, the wall of the dilator 54 collapses around the needle60 as the shoulder 98 seats into the recess, thereby securing thedilator 54 on the needle 60 and blocking separation of the dilator 54and needle 60.

Although the invention has been described in terms of a shoulder 98 andmating recess, alternative dilator-needle attachment mechanisms such asbumps, grooves, slots, wedges, tabs and other mechanisms are alsoincluded within the scope of the claimed invention. The dilator 54preferably includes one or more relief ports 104 to facilitateconvenient needle connection. The relief ports 104 may be formed at theends of the longitudinal slots 102 or at various high-resistancelocations along the dilator 54. The relief ports 104 decrease therigidity or resistance of radially outward expansion of the dilator walland, reduce the amount of force required to insert or securely attachthe needle 60 to the dilator 54. In yet another embodiment, superficialbands or rings, arc-shaped slots, superficial grooves or othermechanisms may be provided to provide improved expansion or attachmentcharacteristics.

A portion of the dilator 54 includes a taper 88 having a decreasingprofile toward the second end 96 of the dilator 54. The taper 88preferably gently cams tissue out of the path of the sling assembly 46as the sling assembly is inserted in the body. The taper 88 is alsosized and shaped to reduce the amount of friction or resistance as thedevice is drawn through the tissues of the patient. The amount of forcerequired to manipulate the device through the tissues is therebyreduced. This in turn provides the user of the assembly with additionalcontrol over device insertion and maneuverability through tissue andwithin the patient. In addition to tapered profiles, other dilatorprofiles such as conical, flared, frusto-conical, pyramid-shaped,elliptical or other applicable profiles may also be used. Overall, theprofile of the dilator 54 is preferably configured to provide easydilation of the tissue to accommodate smooth passage of the sling42/sling assembly 46 and subsequent collapse of the surrounding tissueto securely anchor the sling 42 into the tissue (after sheath removal).

In other embodiments of the invention shown in FIGS. 12A and 12B, thedilator 54A or 54B includes a sling fastening snap mechanism 106 on oneend of the dilator. The embodiment disclosed in FIG. 12A includes akeyed/locking mechanism on its other end. As shown in FIG. 12A, thefirst end of the dilator 54A includes a slot or slot-shaped opening 110configured for convenient insertion of one end of a sling 42 (such asone made from autologous tissue) or sling assembly 46 either at thesurgical site (e.g. by the operating room nurse or surgeon) or otherlocation (such as manufacturing location). Additional shapes for thedilator opening 110 include, without limitation, oval, circular, square,rectangular and other shapes. The slot-shaped opening 110 is locatedalong a portion of the longitudinal axis of the dilator 54A.

Referring to FIG. 12B, a snap-like element 112′ is located on an outersurface near the first end of the dilator 54B. The snap-like element112′ includes a barb or spike 114 that fits within an opening 116situated near the first end of the dilator 54B. The opening 116 for thebarb 114, preferably configured perpendicular to the slot-shaped opening110′, is sized and shaped to match or mate with the barb 114 of thesnap-like element 112′. When the barb 114 is filly seated within theopening 116 of the dilator 54B, the tip 118 of the barb 114 extends intothe slot-shaped opening 110′ of the dilator 54B. A first ridge 120 and asecond ridge 122 located along the length of the barb 114 further secureand/or fasten the barb 114 within the opening 116 of the dilator 54B.Other fastening configurations including, but not limited to, bumps,shoulders, tabs, detents, tongue in grooves, snaps and any combinationsof fastening means may also be used with the present invention.

During use, one end of the sling 42, sheath 44 or sling assembly 46 isinserted into the slot 110′ of the dilator 54B. With the end of thesling 42/sling assembly 46 properly positioned within the slot 110′, thebarb 114 of the snap-like element 112′ is inserted into the opening 116of the dilator 54B. The barb 114 is fully seated within the opening 116when both ridges 120, 122 pass through the opening 116 of the dilator54B. This causes the tip 118 of the barb 114 to bear down on orpenetrate a portion of the sling 42/sling assembly 46 extending withinthe slot 110′ of the dilator 54B, thereby securely fastening the sling42/sling assembly 46 to the dilator 54B.

A keyed/locking mechanism 108 is located near the second end 56B of thedilator 54B. As shown in FIG. 12B, a square-shaped opening 124 extendsalong a portion of the longitudinal axis near the second end 56B of thedilator 54B. The shape of the dilator opening 124 matches thesquare-shaped perimeter of the keying-segment 126 located near the firstend 58 of the needle 60 and allows keyed-rotation of the dilator 54B atninety-degree intervals. Other appropriate shapes for the dilatoropening 124 may also be used provided that the shape of the opening 124complements the corresponding keying-segment shape located near thefirst end 58 of the needle 60. When the first end 58 of the needle 60 ispositioned within the dilator 54B, the square-shaped opening 124 of thedilator 54B together with the keying-segment 126 of the needle 60prevents axial rotation of the dilator 54B relative to the needle 60and, thus, twisting of the sling 42/sling assembly 46. This optionalfeature provides the practitioner or user of the assembly with improvedcontrol and maneuverability of the assembly before and during theinsertion procedure.

The dilator 54B also includes a locking mechanism 128. Referring to FIG.12B, the locking mechanism 128 comprises one or more tension-loaded ribslocated within the longitudinal opening of the dilator 54B. Theconfiguration of the ribs generally matches and corresponds to acomplementary recess 130 located near the first end 58 of the needle 60.Thus, the first end 58 of the needle 60 is inserted through thelongitudinal opening 124 of the dilator 54B until the ribs of thedilator 54B seat within the recess 130 of the needle 60. The dilator 54Bis securely attached or locked onto the needle 60 when the dilator ribsare fully seated within the needle recess 130. Although the inventionhas been described in terms of a rib and complementary recess,alternative dilator-needle attachment mechanisms, such as thosepreviously described, are also included herein.

Referring to FIG. 13, in an alternate embodiment of the invention, thesheath 44 (or sling 42 or assembly 46) is attached to the dilator 54Cvia a locking (or compression) collet 132 and adapter connector 134. Thecompression collet 132 comprises a ring-shaped portion 136 having one ormore barbed snap tongs 138. The complementary adapter 134 comprises acylindrical element 140 having a first end 142 and a second end 144. Theinternal profile near the first end 144 of the adapter connector 134includes a tubular lumen or channel 146, having one or more recesses,shoulders, grooves or similar indentations 148, surrounding an internalprong 150. The second end 144 of the adapter connector 134 includes oneor more barbed snap tongs 152, similar to the tongs 138 of thecompression collet 132. In addition, the first end 52 of the dilator 54Cincludes a longitudinal opening 154 having one or more recesses,grooves, slots or related types of indentations 156 configured to engagethe tongs 152 of the adapter connector 134.

In use, one end of the sling 42/sling assembly 46 of the presentinvention is configured into a tubular or appropriate shape that enablesa sufficient portion of the end of the sling 42/sling assembly 46 to beinserted through the compression collet 132. The tongs 138 of thecompression collet 132 are then inserted into the first end 142 of theadapter connector 134, causing the tongs 138 to snap into engagementwith the adapter connector 134. The end portion of the sling 42/slingassembly 46 is compressed between the tongs 138 of the compressioncollet 132 and the internal prong 150 of the adapter connector 134,thereby securely fixing the sling 42/sling assembly 46 to thecollet/adapter assembly. In a similar fashion, the tongs 152 of theadapter 134 are then inserted and snap-locked into the first end 52C ofthe dilator 54C, creating a secure fixation between the collet/adapterassembly and dilator 54C.

In another embodiment of the invention, the length of the dilator 54D issubstantially equivalent to the length of the needle 60 used for thesling delivery procedure. For example, as shown in FIGS. 14A and 14B,the dilator 54D comprises a hollow, ataumatic trocar-shaped componentgenerally made of a soft, semi-flexible material, such as high densitypolyethylene, polypropylene, polyvinyl chloride (PVC),polytetrafluoroethylene (PTFE) or other similar materials, includingcombinations thereof. The material and design of the dilator 54D allowsthe dilator to be positioned over or passed along the length of theneedle 60, thereby totally or partially encasing the needle 60, similarto an Amplatz sheath/dilator. In the spirit of convenience and brevity,this embodiment of the dilator 54D will be hereafter referenced as thecystoscopy aid 54D. Optionally, tongue and groove structure may besupplied in the needle 60 and cystoscopic aid 54D to guide thecystoscopic aid 54D along the needle 60.

Alternatively, the hollow portion or internal lumen 158 of thecystoscopy aid 54D may be sized and shaped to accommodate passage of adilator 54 and/or sling 42 and/or sling assembly 46, similar to thosepreviously described. As such, after the cystoscopy aids 54D arepositioned over the needles 60, the dilators 54 and/or sling 42 and/orsling assembly 46 are connected onto the ends of the needles 60. Theneedles 60 and attached components are then pulled through the internallumen 158 of the cystoscopy aids 54D until the sling 42 is positionedadjacent the target site or urethra 16 and the needles 60 connectedcomponents are withdrawn from the patient. With the sling 42 properlypositioned in a therapeutically effective relationship with the urethra16, the cystoscopy aids 54D are then removed from the patient, allowingthe tissue to gently collapse around the sling 42. This configuration ofthe device allows components such as dilator 54, sling assembly andsubsequent needle maneuvering to be performed substantially within thehollow portion 158 of the cystoscopy aid 54D, thereby reducing potentialtissue trauma and infection.

In an alternate embodiment, one or more apertures or perforations 160,that function to facilitate verification of bladder and urethraintegrity, are disposed along the length of the cystoscopy aid 54D. Forexample, during use, after the needles 60 have been inserted within thepatient, the cystoscopy aid 54D may be pushed along the exterior surfaceof each needle 60. If the bladder has been punctured during needleinsertion causing urine leakage or drainage within the patient, theurine or bladder fluid will enter the apertures 160 of the cystoscopyaid 54D and flow along the surface and out from the needle 60. Thisallows the practitioner to quickly and easily confirm urethra andbladder integrity.

In another embodiment of the invention, shown in FIG. 14C, a first end162 of the cystoscopy aid 54E is attached to an end of a sling 42, orsling assembly 46 or portions thereof. The sling 42/sling assembly 46may be attached to the cystoscopy aid 54E using attachment mechanismsand techniques similar to those previously described throughout thisdisclosure. Following handle 64 removal, cystoscopy aid 54E is pushedalong the exterior of a needle 60 to maneuver and properly position thesling 42/sling assembly 46 in a therapeutic position relative toanatomical structures such as the urethra or bladder.

Alternatively, the cystoscopy aid 54E or dilator 54 may include a hollowportion configured to house the sling assembly 46. In other words, thesling 42/sling assembly 46 would be folded, rolled or similarlyconfigured for placement inside the hollow portion of the dilator orcystoscopy aid 54E. One role of the dilator 54E or cystoscopy aid 54E inthis embodiment, similar to that of the sheath 44, is to reduce frictionor tissue trauma as the sling 42 is drawn through the various tissues.It is noted that the sheath 44 is a wholly optional element of thepresent invention. The embodiment of the present invention shown in FIG.14C is believed to potentially reduce sling assembly componentcontamination/exposure and wound infection.

In an alternate embodiment of the invention, a set of grasping jaws 164may incorporate a dilator, as shown in FIGS. 15A and 15B. Preferably,the jaws 164 are constructed from a bioabsorbable material. A first end166 of the jaws 174 attaches to the needle 60 via a snap or quickfitting attachment. A second end 168 of the jaws 164 attaches or clampsonto the sling 42 or sling assembly 46. Optionally, the jaws 164 mayserve to anchor the sling 42 within tissue of a patient.

The mechanism by which the jaws 164 attach to and release the sling 42or sling assembly 46 may be similar to that of a bioptome. Otherexemplary mechanisms such as a ball-detent used on a ratchet wrench,spring loaded clamps, memory alloys, and other mechanisms may also beused. The jaws 164 may optionally be operably connected to andcontrolled by the handle 64 of the device. Manipulation of the handle 64causes the jaws 164 to open and close, thereby enabling the device toclamp onto and/or release the sling 42 or sling assembly 46. Inaddition, the handle 64 may be further manipulated to detach the jaws164 or a portion thereof from the needle 60. As such, once the sling 42or sling assembly 46 is properly located within the patient (furtherdescribed below), the bioresorbable jaws 164 are detached from theneedle 60 either inside or outside the body of the patient.

Referring to FIG. 16A, the needle 60 is generally curved or arcuate.Preferably, the needle is arc-shaped and includes a first end 58 and asecond end 62. Although a variety of needle designs and/orconfigurations may be used including, without limitation, straight,bent, curved, arc-shaped, Stamey, Raz and other configurations, allreferences hereinafter will be made to an arc-shaped needle in thespirit of brevity and reader convenience.

Overall, the shape of the needle 60 should facilitate and providecontrolled passage of the needle 60 through tissue, preferably from anabdominal incision to the vagina or, alternatively, from the vagina toan abdominal incision. The ends or tip of the needle 60 are preferablynot sharpened, but may be tapered to afford easy passage through tissuewhile providing a blunt surface that avoids cutting sensitive tissuesuch as the bladder or urethra. In a preferred embodiment, the length Nof the needle 60 is approximately within the range of 16.5 cm to 24.1 cm(6.5 inches to 9.5 inches) and has a preferred external diameter ofapproximately 3.175 mm (0.125 inch). It is preferred that the diameterof the needle 60 be small relative to the prior art to reduce tissuetrauma.

The needle 60 is made of a malleable, yet durable, biocompatablesurgical instrument materials such as, but not limited to, stainlesssteel, titanium, Nitinol, polymers, plastics and other materials,including combinations of materials. The needle 60 should havesufficient structural integrity to withstand the various forces (e.g.forces caused by dilator attachment, cystoscopy aid passage, andpenetration/passage of the needle 60 through the various tissues)without undergoing any significant structural deformation. Optionally,the needles 60 could be sufficiently malleable to allow a practitioneror user of the device to modify the needle 60 to a desired shape and,thereby, optimize the procedural approach.

As shown in the embodiment of FIG. 16A, the first end 58 and second end62 of the needle 60 may include a keying feature 170 affording secureassociation between the needle and handle 64 and/or dilator 54 and/orsheath assembly 46. In one embodiment, the keying feature 170 comprisesa recess 130 and/or square-shaped portion 126. As previously described,the recess 130 and square-shaped portion 126 are designed forcomplementary engagement to the appropriate end of a dilator 54 orhandle 64. Another embodiment of the invention includes a reversiblekeying feature. The reversible keying feature allows the handle 64 to beinterchangeably attached yet securely affixed to either end of theneedle 60. In a preferred embodiment, the needle 60 may be substantiallysymmetric about a centerpoint, that is, the radius of curvature of theneedle 60 may be substantially constant and either a handle or a dilatormay be attached to either end of the needle 60.

In an alternate embodiment, the keying feature of the needle 60Bcomprises an end cap 172 and an elongate reduced width segment 174having a square-shaped cross sectional profile, as shown in FIGS. 16B to16D. The second end 62B of the needle 60 shown in these Figures isinserted into the keying feature or channel 176 that extends along thelongitudinal axis of the handle 64B (partially shown in FIGS. 16D to16F). When the needle 60B is properly positioned within the handle 64B,a yoke or other fastening component 178 receives and secures theelongate segment 174 in the narrow portion 180 of the channel 176, asshown in FIGS. 16D and 16E. The complementary configuration of thechannel's narrow portion 180 and the needle's elongate segment 174prevents the handle 64B from rotating around the axis of the needle 60B.In addition, this configuration may also provide additionalneedle/handle stability and improved tactile feedback for a user of thedevice.

The present invention may optionally include structure that allows thesurgeon to change the orientation or position of the handle relative tothe needle. The handle may be rotatably repositioned relative to theneedle or, in some embodiments, the handle may be axially slidable andrepositionable along the length of the needle. The handle may berepositioned in any orientation as determined by the surgeon or it maybe indexed between a plurality of predetermined orientations dependingon the particular embodiment of the present invention.

FIG. 16E illustrates the needle seated in a locked position relative tohandle 64B. In order to rotate the handle 64B, a user or practitionermanipulates a trigger or button that actuates the fastening component178 thereby causing the channel 176 to disengage from the elongatesegment 174, as shown in FIG. 16F. In this position, segment 174 of theneedle 60B is no longer seated in the handle 64B. With the elongatesegment 174 positioned in the wider portion 182 of the channel 176, theneedle 60B is free to rotate. However, the configuration of the needle'send cap 172 prevents the needle 60B from becoming completely disengagedfrom the handle 64B. Thus, the keying features maintain the needle 60Bin proper alignment with the handle 64B when in the locked position andalso allow a user to controllably rotate the needle 60B to obtain adesired handle 64B orientation.

In an alternate embodiment of the invention, the needle 60C comprises anassembly 184 having one or more detachable components. For example,referring to embodiments shown in FIGS. 17A and 17B, the needle assembly184 comprises a body portion 186 and one or more segments 188. Anexternal thread 189 formed near the end of the body portion 186 allowsneedle segments 188, dilators 54, slings 42, or sling assembly 46 to bescrewed onto the body portion 188 thereby forming the needle assembly184. In addition, the devices may be easily removed by simply unscrewingthem from the body portion 186 of the needle assembly 184. Otherconfigurations or designs of the needle assembly 184 may include, butare not limited to, hollow or solid body portions 186, snap fit, memoryalloy or latching mechanisms, internal threading or other designs.

In another embodiment, the handle 64 may be permanently attached to anend 62 of the needle 60. More particularly, the handle 64 may be rigidlyaffixed to the needle 60 so that substantially no relative movement mayoccur between the needle 60 and the handle 64.

Referring to FIG. 18A, one embodiment of the adjustable handle 64Gcomprises a relatively smooth, ergonomic body made of delrin, ABS,nylon, polycarbonate, acetal, polyetherimide, polysulfone or othersterilizable materials. The body of the handle 64G may be hollow, solidor semi-solid. One or more surfaces of the handle include a plurality ofridges 190 and/or indentations 192 that provide an enhanced grippingsurface for a user of the device. Alternatively, various portions of thesurface of the handle 64G may also include grasping features such asbumps, grooves, ridges or other gripping means, that enable improvedmanipulation of the handle 64G. In addition, the handle 64G may includean indentation formed near the middle 194 of the handle 64G thatprovides a user of the device with better control of, and an improvedgrip on, the handle 64G.

A push button 198 and keyed opening 200 are located near the needleattachment end 196 of the handle 64G shown in FIG. 18A and form a keyingfeature of the handle 64G. As shown in FIG. 18B, the push buttonassembly 198 comprises a button or knob-shaped component 202 thatattaches to a yoke 204 (attachment locations indicated by dashedreference line). In particular, the yoke 204 is attached to the button202 via snap tongs 206 that lock the button 202 and yoke 204 together.Prior to attachment, the button 202 and yoke 204, including a spring208, are fitted within their respective grooves and/or slots formed nearthe needle attachment end 196 of the handle 64G, as generally shown inFIG. 18C. The spring 208 provides the appropriate tension to maintainthe assembly in a locked position.

When the assembly is in a locked position (shown in FIG. 18D), thespring forces push the button 202 in a direction away from thelongitudinal axis of the device. This in turn causes the groove orrecess 210 of the attached yoke 204 to protrude within the keyedlongitudinal opening 200 resulting in a non-square-shaped opening formedalong an axial portion near the needle attachment end of the handle 64G.In the locked configuration, the handle 64G is securely attached in astationary position on the needle 60. Pressing or pushing the button 202inwardly toward the axis of the device unlocks the device and creates asquare-shaped or keyed opening 200 for the needle 60. FIG. 18Eillustrates a cross-section of the keyed, longitudinal opening 200 in anunlocked position.

The quick-release push button of the handle 64G enables a user of thedevice to easily attach or detach the handle 64G from the needle 60 orreposition the orientation of handle 64G relative to the needle 60,using one hand. While gripping the handle 64G, the user of the devicesimply depresses the push button 202 with one finger to unlock thehandle. Still using a single hand to control the handle 64G, the usercan then insert one end of the needle 60 into the keyed opening 200 ofthe handle 64G and, upon releasing the button 202, secure the handle 64Gto the needle 60.

As previously disclosed, the needle 60 includes a similar keying featureconfigured for complementary engagement with the keyed portion of thehandle 64G. These complementary, square-shaped keying features allow apractitioner or user of the device to rotatably index the handle 64Gbetween predetermined positions located in ninety-degree incrementsaround the needle axis. Thus, the practitioner may position the handle64G in a preferred configuration on the needle 60 that provides thegreatest comfort and ease of insertion. In addition, via the lockingmechanism, the keying features also prevent the handle 64G fromuncontrollably rotating around the axis of the needle 60, for instance,during a sling or needle insertion procedure. Although the invention hasbeen described with respect to a square-shaped keying feature, othergeometrical configurations and keying means are also included within thescope of the present invention.

Another embodiment of needle attachment mechanism for a handle is shownin FIGS. 19A to 19C. The handle 64H includes a quick-release feature 212comprising one or more levers 214 and an associated border or frame 216that surrounds an opening 218. The opening 218 is generally located nearthe needle end of the handle 64 and along the longitudinal axis of thedevice. The frame 216 bordering the opening 218 may include variousindentations or ridges 220 that provide improved gripping capabilities.In addition, the handle may also include a square-shaped keying feature222 similar to the previously described keying features. A differentshaped handle 64I is shown in FIGS. 19B and 19C.

During use, a practitioner or user of the device simply compresses thelevers 214 of the handle 64H together using, for example, a thumb andforefinger. Compression of the levers 214 changes the configuration ofthe frame 216 and opening 218 to allow insertion of a needle 60 therein.The user of the device releases the levers 214 when the needle 60 isproperly positioned within the handle 64I, causing a portion of theframe 216 to compress against a portion of the needle 60 (e.g., arecessed portion) thereby blocking axial movement of the needle relativeto the handle 64I and securely attaching the handle 64I onto the needle60. The handle 64I can be quickly released from the needle 60 bypressing on the handles 214.

Another embodiment of a quick-release feature for the handle 64K isshown in FIGS. 20A-20C. For this embodiment of the invention, the handle64K may be made from a single molded or machined component. Aquick-release button 224, located near the needle end of the handle 64K,controls a keyed needle-latching mechanism 226. As best seen in FIG.20B, the needle latching mechanism 226 generally includes ageometrically shaped opening section 228, a locking section 230 and anend section 232. When a practitioner or user of the device depresses thequick-release button 224, the semi-resilient material of the handle 64Kcauses displacement of the locking section 230, thereby allowing theneedle 60 (not shown) to be inserted into the latching mechanism 226 ofthe handle 64K. After the needle 60 and handle 64K are positioned oraligned according to user preference, the button 224 is released causingthe locking section 230 to return to its initial configuration and, inso doing, seat within the complementary, recessed feature of the needle60. This not only secures or locks the handle 64K onto the needle 60 butalso prevents the handle 64K from rotating around the needle axis.

In another embodiment of the invention, the keyed, locking portionand/or quick release feature of the handle 64K may be located near themiddle of the handle 64K, near the end of the handle 64K close to theneedle (FIG. 18A) or at any preferred location on the handle 64K. Alarge or small section or length of the needle 60 may be housed withinand contact the handle 64K of the device, thereby providing enhanceduser-control and stabilization of the needle 60 relative to handle 64K.The increased surface contact between the needle 60 and handle 64K mayalso strengthen the associated gripping or frictional forces, resultingin improved locking or attachment capabilities of the device.

The associated quick-release feature (such as push button 198, button224, levers 214, etc.) may also be positioned at any preferred locationon the handle 64 of the present invention. For example, referring toFIGS. 21A and 21B, positioning the button 202 opposite to the needleinsertion end 196 of the handle 64L may reduce or prevent accidentaltriggering of the button 202. Further, this particular design mayprovide additional ergonomic advantages for the user of the device. Forexample, the bottom could be flush or recessed with the surface of thehandle.

Various configurations of the overall size, weight and shape of thehandle 64 are also included within the scope of the claimed invention.Still referring to FIGS. 21A and 21B, another embodiment of the handle64L comprises a compact profile. The smaller size of the handle 64Lreduces the weight of the handle 64L, thereby making the device 40 lessheavy at the top and better balanced. Alternatively, the handle 64L mayalso be configured to be permanently, but rotatably, affixed to theneedle 60 (not shown). As such, the user or practitioner may rotate thehandle 360° around the axis of the needle 60 and lock the handle 64L inposition once the desired orientation is reached.

FIG. 11 illustrates an alternate embodiment of the present inventionthat includes a slidable second handle 64′ which may be used alone or incombination with handle 64. In general, the slidable handle may provideadditional ergonomic advantages and control during the needle insertionprocedure. For example, when used in combination with the handle 64, theslidable handle 64′ is initially positioned and optionally locked nearthe first end 58 of the needle 60. During needle insertion (furtherdescribed below), the slidable handle allows the user or practitioner tomaneuver the needle 60 more accurately along the insertion pathway. Inthe example of an initial suprapubic approach, after the slidable handle64′ comes close to or in contact with the abdomen, the slidable handle64′ is unlocked and repositioned closer to the handle 64. The slidablehandle is then secured at the new position and locked in place, therebyallowing further insertion of the needle 60.

The second handle 64′ may optionally be locked in a position that blocksinadvertent lurching of the needle 60 within the tissue. Preferably, thesecond handle 64′ is sized and shaped to engage the abdominal tissue toact as a stop to prevent further penetration of the needle 60 until thesecond handle 64′ is unlocked and moved to a location closer to thehandle 64. This feature is believed to be useful in resistinguncontrolled passage of the needle 60 into the retropubic space afterthe end 58 of the needle 60 bursts through the tough rectus fascia. Oncethe rectus fascia is penetrated, the second handle 64′ is unlocked andmoved to a location closer to the handle 64 and the needle can becontrollable passed through tissue.

Optionally, the second handle 64′ may include means for affordingsliding of the handle 64′ toward the handle 64, but that resistsmovement of the handle 64′ away from the handle 64. The means maycomprise a plurality of ribs within handle 64′ that engage the needle 60and that are angled toward the handle 64.

Referring to another embodiment shown in FIGS. 22A and 22B, a slidablehandle 204 comprises a body portion 206 (partially shown in FIGS. 22Aand 22B), latch 208, o-ring 210 and spring ring 212 contained in ahandle cavity 207. In general, the body portion 206 and latch 208 may bemade of delrin, ABS, nylon, polycarbonate, acetal, polyetherimide,polysulfone, or other sterilizable materials. In addition, the o-ring210 and spring ring 212 may be made from high durometer polyurethane,teflon and other rigid or semi-rigid materials.

The frustro-concially shaped spring ring 212 comprises a first end 214,a second end 216 and a lumen 218. In general, the external diameter ofthe first end 214 of the spring ring 212 is greater than the externaldiameter near the second end 216 of the spring ring 212, thereby formingan inclined surface. The lumen 218, situated along the axis of thespring ring 212, is configured to slidably engage a needle 60.

Located adjacent to the spring ring 212 is a frusto-cylindrically shapedo-ring 210. The o-ring 210 comprises a first end 220, a second end 222and a lumen 224 having a first surface 226 and a second surface 228. Thefirst surface 226 of the lumen 224 is located near the first end 220 ofthe o-ring 210 and forms an incline configured for complimentaryengagement with the inclined surface of the spring ring 212. Incontrast, the second surface 228 of the lumen 224 is located near thesecond end 222 of the o-ring 210 and is designed to slidably engage theneedle 60.

Adjacent to the o-ring 210 is a latch 208 comprising two posts 230 andtwo tabs 232, wherein similar ends of each post 230 are attached to atab 232. In addition, the posts 230 border the needle 60 inperpendicular alignment with the needle axis, thereby forming, togetherwith the tabs 232, a frame around a portion of the needle 60. One end234 of each post 230 also includes a flange 236 that triggers thelocking mechanism of the handle 204. The handle 204 is locked onto aneedle 60 by depressing a tab 232 so that the flange 236 contacts aportion of the o-ring 210 and causes the o-ring 210 to engage the springring 212. The force of the o-ring 210 against the spring ring 212compresses the longitudinal length and causes radial expansion andcompression of the spring ring 212, thereby generating frictional forcesamong the spring ring 212, needle 60 and handle cavity 207. Thesefrictional forces prevent needle movement in the longitudinal direction(i.e. along the needle axis). To prevent handle 204 rotation on theneedle 60, a projection 238 may be formed on an external surface of theo-ring 210 and configured for complimentary engagement with anindentation 240 formed on an internal surface of the handle 204.Further, the handle 204 may be unlocked in a similar fashion by simplydepressing the other tab 208 and, thereby, releasing the compressiveforces which causes the components to disengage.

FIG. 22B illustrates an embodiment of lockable handle similar to that ofFIG. 22A. Elements in FIG. 22B have been given reference characterssimilar to those of FIG. 22A, to which the suffix “B” has been added.

Referring to FIGS. 23A-23C, an alternate embodiment of the slidablehandle comprises a body portion, o-ring 212, spring ring 210 and slider242 contained in a handle cavity. The o-ring 210 and spring ring 212 ofthis embodiment of the slidable handle 204 are similar to thosepreviously described. However, the cylindrically shaped o-ring 210includes at least one rod 244 extending perpendicular to the needle axisand partially projecting from the cylindrical surface of the o-ring 210.

The slider 242 of the handle 204 comprises two shafts 246, that pivot ona rod (not shown) about a pivot point 248, and a switch 250. In general,the shafts 246, switch 250 and rod 244 may be made from substantiallythe same materials, such as delrin, ABS, nylon, polycarbonate, acetal,polyetherimide, polysulfone or other similar materials. The first end252 and second end 254 of each shaft are configured to securely engagethe switch 250 and rod 244, respectively, thereby forming the sliderassembly. The slider 242 in combination with the o-ring 219 and springring 212 are the mechanisms by which the needle 60 and handle 204 may belocked and unlocked.

For example, a user locks the handle 204 by pushing or pressing theswitch 250 in one direction. This action causes the shafts 246 to movethe o-ring 210 into complementary engagement with the spring ring 212.As previously described, the resulting frictional forces prevent lineardisplacement of the needle 60, thereby securely locking the handle 204onto the needle 60. The handle 204 may be unlocked by simply pushing theswitch 250 in the opposite direction.

In another embodiment, shown in FIGS. 24A-24D, the slidable handlecomprises a body portion 206, upper block 256, lower block 258, loaddistributor 260 and force providing member 262 (e.g. a cam). The bodyportion 206 of the handle 204 may be made of materials similar to thosedescribed in previous embodiments. In addition, the lower and upperblocks 258, 256 may be made of high-density polyurethane, whereas theload distributor 260 and force providing member 262 may be made of amaterial with a high coefficient of friction.

Referring to FIGS. 24A-24C, the generally square-shaped blocks 256, 258include a channel 264 formed within a portion of each block. Thechannels 264 are configured to house a needle 60 when the blocks 256,258are properly aligned within the handle body 206. In addition, ridges,bumps, or other similar gripping features are formed on the surface ofeach channel 264 to enhance the needle gripping capabilities of theblocks 256,258.

The handle of FIGS. 24A-24E locks onto a needle 60 by depressing theforce providing member 262. The force providing member 262 forces theupper block 256 into close proximity with the lower block 258,subsequently compressing or sandwiching the needle 60 therebetween. Thecompression forces, which are evenly displaced via the load distributor260, together with the gripping surfaces of the blocks 256,258 preventlinear displacement of the needle 60 relative to the handle when lockedwithin the handle body 206, as shown in FIG. 24D. Although the grippingfeatures should sufficiently prevent the handle body 206 from rotatingabout the needle axis, additional keying features may also be added. Forexample, the needle 60 and needle lumen 268 of the handle body 206 mayinclude complementary features, such as flattened surfaces 270 shown inFIG. 24E, that provide added stability to the present invention.

Referring to FIG. 25, an alternate embodiment of the locking mechanismof the slidable handle 204 comprises an upper clamping block 272, lowerblock (not shown), two cams 276, a rod 278 and two pins 280. The needleis designed to be placed between the upper and lower blocks andsandwiched therebetween. Rotation of the wheel cams 276 provide balancedpressure on clamping block 272.

In another embodiment of the present invention, the slidable handle 204comprises a body portion 206 and locking mechanism 282. The body portionmay be made from silicone rubber or other elastomeric materials. Asshown in FIG. 26, the body portion 206 includes a barbed inner lumen 284that functions as the locking mechanism for the needle 60 (not shown).As such, the orientation of the barbs prevent the slidable handle 204from sliding in one direction along the needle 60 (e.g. toward the endof the needle that is placed in the tissue), yet permit the handle 204to slide in the opposite direction along the needle 60. This allows thepractitioner to use the slidable handle 204 to control or guide theneedle 60 through tissue and also reposition the slidable handle alongthe length of the needle 60.

Another embodiment of the locking mechanism is shown in FIG. 27. Thismechanism is similar to the embodiment of the locking mechanismreferenced in FIGS. 24A-24E. However, instead of depressing a cam 262, auser depresses a button 286 that latches into a mating release element288. Yet another embodiment of a locking mechanism, shown in FIG. 28,comprises a screw-like device 290 that can be locked and unlocked simplyby twisting or rotating a portion of the device 290. Other embodimentsof locking mechanisms are also included within the scope of the claimedinvention.

In another aspect, the present invention comprises a kit for treating apatient (e.g. for SUI). The kit preferably comprises at least twoneedles, an implantable material for supporting structure and at leasttwo dilators. Two or more needles reduces the need to reuse a needle ata different location with a patient, thereby eliminating crosscontamination issues. Additional needles, dilators and other elementsmay also be included for surgical convenience, for avoidance ofcontamination from one portion of the body to another, for ease ofmanufacturing or sterilization or for surgical requirements. Forexample, four needles may be utilized to implant the sling of FIG. 41.The needles would pass through abdominal incisions and through a vaginalincision.

Optionally, the sling 42 may includes a means for determining thetension in the sling. The tension determination means may comprise anelement attached to the sling or incorporated in the sling that iscapable of measuring sling tension.

The elements of the assembly of the present invention may be any color.Preferably, the elements are of constructed to be a color that contrastswith the intended physiological environment and with other elements. Forexample, the sling 42 is preferably white and the position adjustmentmember 66 may be blue. This helps the surgeon identify the location anddiscern the elements of the assembly.

Examples of Methods

Many methods are contemplated herein. Although the methods of use asdisclosed herein generally relate to female incontinence conditions andtreatments/procedures, male incontinence conditions andtreatments/procedures are also included within the scope of the presentinvention. Procedures that address problems other than incontinence(e.g. cystocele, enterocele or prolapse) are also contemplated alone orin conjunction with the present invention. Further, the term “urethra,”with respect to sling positioning, is used for brevity and readerconvenience. It should be noted that the present invention isparticularly suitable for placing a sling in a therapeutically effectiveposition. The method may be utilized to support a variety of structuresat different anatomical locations. As such, the terms “target site,”“bladder”, “urethro-vesical juncture”, “vaginal vault”, “U-V juncture”and “bladder neck” are also included within the scope of the presentinvention.

Referring now to FIGS. 29A through 30C, a preferred embodiment ofsurgical procedure for treating female incontinence is disclosedaccording to an aspect of the present invention. Initially, the patientis placed under local, spinal or general anesthesia. A small transverseincision 404 is made in the anterior vaginal wall 20 of a female patientfollowed by a transurethral dissection. Two small transverse suprapubicabdominal stab incisions 400 are also made near the back of the pubicbone (e.g. each about 1 cm from the midline, or alternatively, one largeincision may be made) to allow for needle entry. Optionally, twoparaurethral dissections (incisions next to the urethra) lateral to themidline may be created to allow the surgeon's finger to meet the end 58of the needle 60 during the procedure.

A handle 64 is optionally adjusted relative to needle 60 according tosurgeon preference and securely associated with the second end 62 of theneedle 60. Optionally, the attachment and configuration of theneedle-handle assembly may be adjusted or customized to user preference.The handle 64 may be optionally released from the needle 60 by pushing abutton or compressing levers located on the handle 64. Once released,the handle 64 can then be rotated or displaced along an axis of theneedle 60 to a preferred position. After the handle 64 is properlypositioned on the needle 60, the button or levers are released, therebycausing the handle 64 to become securely attached to the needle 60.

FIG. 29A shows the second end 58 of needle 60 just passing an abdominalincision 400. Preferably, after the second end 58 of the needle 60passes the suprapubic abdominal incision 400, the surgeons seeks toencounter resistance associated with the posterior portion of thepatient's pubic bone 402 with the second end 58 of the needle 60 tocontrollably move the end 58 of the needle toward the vaginal incision404 and to help avoid damaging structures such as the urethra andbladder of the patient. The second end 58 of the needle 60 is used toidentify the location of the pubic bone 402. The surgeon exploits theresistance provided by the pubic bone 402 to controllably pass the endof the needle 58. This approach is preferred as it helps keep the needle60 away from major pelvic vessels, nerves and anatomical structures suchas the urethra, bowels and bladder.

FIG. 29B illustrates the end of the needle as it just passes thesuprapubic incision. FIG. 29C illustrates the needle 60 as the surgeonexperiences the tactile feel of the resistance provided in part by theposterior portion of the pubic bone 402. FIG. 29C shows the needle 60 asit passes in proximity to the posterior surface of the pubic bone 402which continues to operate as an anatomical guide for the surgeon as theneedle end 58 approaches vaginal incision 404 (see FIG. 29D).

FIG. 30A is a schematic end view generally illustrating regions to avoid390 during the surgical procedure and preferred passage region 385.Deviation of the end 58 of the needle 60 outside of the preferredpassage region 385 into the regions to avoid 390 is believed to increasethe potential for damaging arteries, veins, organs, lymph tissue andother tissues that are likely to lead to complications. Passing theneedle 60 in the preferred passage region 385 avoids contact between theend of the needle 58 and these structures.

FIG. 29D illustrates the needle as it passes out of a vaginal incision404. The surgeon typically holds the handle 64 of the needle 60 duringthis time by using predominantly one hand. Optionally, with the indexfinger of the opposite hand, the surgeon may meet the end 58 of theneedle via the paraurethral dissection. The surgeon's finger may bedelicately placed adjacent endopelvic fascia of the patient and used toguide the needle 60 through the relatively tough endopelvic fascia andinto the vaginal incision 404. This helps the surgeon keep away fromstructures such as the bladder, urethra and other sensitive tissue.

The small diameter and curvature of the needles 60 help to provideprecise passage of the needles 60 to the vaginal incision 404. Inaddition, this needle configuration creates a minimally invasive pathwaythrough tissue extending between the abdominal wall and pubic space,thereby reducing the risk of perforating the bowel and/or blood vesselsand nerves located lateral to the bladder 14.

The steps described above are repeated as needed for a second needle 60on the other side of the urethra 16. FIG. 30B is a schematic end viewshowing two needles placed in a patient and ready to receive a sling orsling assembly. Once both needles are placed, surgeons typically performa cystoscopy to ensure that the bladder is not punctured beforeimplanting the sling. A cystoscopy confirms the integrity of the bladder14 and urethra 16 or recognizes a bladder perforation. The plasticcystoscopy aid shown in FIG. 14A may optionally be used for thispurpose. The cystoscopy aid may be used separately or in conjunctionwith cystoscopy.

FIG. 30C is a perspective view of a sling system associated with twoneedles 60. To attach the sling assembly, the plastic sheath 44 isoriented so that the optional center orientation indicia (e.g. a bluemark) is facing away from the surgical field, toward the surgeon. Thedilators 54 are then pushed onto the ends 58 of needles 60 as shown inFIG. 30C. The dilators 54 are preferably snapped irreversibly into placefor a secure connection. Also preferably, the dilators 54 are connectedto the needle in a fashion that prevents rotation of the dilators 54relative to the needles 60.

Alternatively, in another embodiment of the invention, the dilator neednot be directly connected to the needles 60 and, instead, a flexibledilator with a lumen (e.g. dilator 54E shown in FIG. 14C) may be pushedalong the exterior portion of the needle 60 in order to implant a sling.Preferably, the dilator of this embodiment is pushed in a direction fromthe vaginal incision 404 toward the suprapubic incision 400, but theopposite direction is also contemplated as within the present invention.

Returning to FIG. 30C, before snapping the second dilator 54 onto thesecond needle 60, the surgeon determines that the majority of anyoptional adjusting filament 66 is facing away from the urethra 16 (seeFIG. 6), and that the sling mesh is untwisted.

Dilators 54, including a pre-attached sling assembly 46, are attached tothe first ends 58 of the needles 60 protruding from the vagina 20. Asdiscussed above, after the first dilator 54 is attached to one needle60, the sling assembly 46 is properly oriented so that the slingassembly 46 is not twisted prior to attaching the second dilator 54 tothe end of the other needle 60. In addition, the sling assembly 46 isoriented so that the larger filament loops (of the position adjustmentmember 66) are facing outward or away from the urethra 16. After thedilators 54 and sling assembly 46 are properly positioned, the dilators54 are securely attached to the needles 60 to ensure that they do notbecome detached as the needles 60 are preferably pulled simultaneouslythrough the tissues of the patient.

Once the dilators 54 are securely attached, the needles are pulled upthrough the suprapubic incisions as shown by the arrows in FIG. 30C,taking care to avoid contact with sensitive tissue. The sling is thenclamped with surgical clamps (not shown). Preferably, the handles 64 areused to pull the needles 60 up through the suprapubic incisions 400.During this portion of the process, the attached dilators 54 and slingassembly 46 are atraumatically pulled up through the needle paths,advancing the sling assembly 46 adjacent to and looped beneath theurethra 16 or target site. A portion of each end of the sling assembly46 extending beyond the suprapubic incisions 400 is clamped and then cutto release the needles 60 and attached dilators 54.

The sling is placed in a therapeutically effective position. The preciseanatomical position will depend upon a variety of factors including thetype and degree of anatomical damage or insufficiency, whether the slingprocedure is combined with other procedures and other surgeon decisions.Typically, the sling is placed midurethra, without tension, but inposition to support the midurethra. Alternatively, the sling could beplaced to support the bladder neck and/or UV junction.

Once the sling assembly 46 is carefully positioned under the midurethraor target site to provide sufficient support to the target site, theoverlapping portion of the sheath 44 located near the center of thesling assembly 46 and the axially located member 66 (i.e. tensioningfilament) may then be used to center and properly position the slingassembly 46 under the midurethra. The sheath 44 is then removed.

FIG. 31A is a perspective view of the sling placed in proximity to theurethra of a patient that shows one method of permanently adjusting theposition or “tension” of the sling during the surgical procedure. Usingthe position adjustment member 66 on the sling mesh to reposition thesling 42, the surgeon pulls down or away from the urethra on the sling42 and position adjustment member 66 using a blunt instrument 372 toshift the sling away from the urethra 16, thereby reducing tension. Theblunt instrument (e.g. a clamp) is used to pull down and, thereby,displace the sling 42 as desired. The position adjusting member 66transfers some of the force placed on the sling 42 by the bluntinstrument 372 to another location on the sling (e.g. the end 61 of thesupport portion II of the sling 42 shown in FIG. 1A). This action isbelieved to be effective in permanently reducing the tension of thesling 42 and increasing the space between the sling 42 and the urethra16, even after the sheath 44 is removed.

Preferably, the position adjustment member 66 is a continuous memberthat extends the length of the support portion II (FIG. 1A) of the sling42 and avoids contact with the vaginal incision 404. This affordsconvenient contact between the sling 42/member 66 and member 372 at anylocation along the length of the support portion II. In contrast, amember 66 that is separated at the mid portion of the sling would bedifficult to engage with member 372. A sling with a continuous,non-separated position adjustment member 66 is particularly helpful, asthe surgeon is working at a remote location in cramped quarters.Additionally, a position adjustment member that hung down into thevaginal incision 404 may cause complications due to interaction with theincision 404.

After achieving the desired sling location, the position adjustmentmember 66 laterally located on both sides of the urethra 16 may be cut(e.g. at the ends 61 of the support portion II) and removed.Alternatively, the position adjustment member 66 may be left in place,particularly if it consists of a degradable material or is an integralpart of the sling 42. The sling 42 is also trimmed adjacent to thesuprapubic incisions 400, thereby removing the excess sling materialextending outside the body of the patient.

Preferably the position adjustment member 66 extends substantially alongthe entire length of the sling 42 (see FIGS. 1 and 1A) so that themember 66 can be used to increase the tension of the sling (e.g.position the sling closer to the urethra). FIG. 31B is a perspectiveview of another method of adjusting the position or “tension” of thesling during the surgical procedure. Sling tension may be tightened byplacing a device, such as a clamp, across one or both ends of the sling42, suprapubically. The entire sling width and the associated member 66should also be captured within the clamp. In addition, the sling 42 maybe rolled or looped around the clamp to improve the grip. As such, theend of the sling 42 is then pulled in an upward direction to tighten thesling 42 as desired. The tension adjustment member 66 transfers some ofthe force provided by the clamp to another location of the sling (e.g.the ends 61 of the support portion II) to more effectively repositionthe sling 42. If necessary, this tightening procedure can also berepeated on the other end of the sling 42 located on the contra lateralside. In contrast, a member 66 that does not extend substantially alongthe entire length of the sling 42 (see FIGS. 1 and 1A) could not be usedto increase the tension of the sling.

Generally, the surgeon grasps the mesh and tensioning filament togetheradjacent the suprapubic incision 400 and pulls to increase the tensionof the mesh. Adjustment may occur before or after the dilators 54 orsheath 44 are separated. FIG. 31C shows the sling after the dilatorshave been cut off, but prior to final trimming.

The position adjustment member 66 may be cut lateral to the urethra onboth sides (e.g. at 61 in FIG. 1) and it is removed prior to the end ofthe surgical procedure. Optionally, it may be left in place after thesurgical procedure. The sling 42 is finally cut to size at thesuprapubic incisions 400 as shown in FIG. 32. After the procedure, thesurgeon closes the suprapubic and vaginal incisions. A Foley cathetermay be used to facilitate voiding at the surgeon's discretion.

The surgeon verifies the proper placement of the sling 42 as the slingmesh may be difficult to move after the plastic sheath 44 is removed.After the dilators 54 are trimmed off as shown in FIG. 31C, the plasticsheath 44 is removed from the sling mesh 42 by pulling up on both sidesof the sheath 44, preferably one at a time, and preferably in thedirection of the arrows of FIG. 31C. Optionally, to avoid overtighteningthe sling mesh 42 while removing the sheath 44, a forceps or other bluntinstrument may be placed between the sling and the urethra.

In an alternate embodiment, the member 66 is not cut and remainsattached to the sling 42. Maintaining filament 66 attachment to thesling 42 affords convenient postoperative adjustments to sling tension.Further, with respect to the embodiment of the invention whereby themember 66 is coated with a radiopaque substance, retaining the member 66allows the practitioner to track post-operative changes to the positionof the sling 42 and/or urethra 16.

The position of the sling may be adjusted using the member 66 even afterthe surgical procedure without requiring a subsequent vaginal incisionand without having any structure passing through the original vaginalincision 404. FIG. 37 is a perspective view of another method ofpermanently repositioning or adjusting the “tension” of the sling. Inthis procedure, typically after the surgical procedure and before anyoptional bioresorbable portion of the filament is absorbed by the bodyor rendered ineffective for the purpose of tension adjustment, thesurgeon places a blunt device in the urethra 16 and pulls down, therebypermanently loosening the tension of the sling 42. This may help avoidthe need to reposition the sling by dissecting the vagina 20 andgrasping the sling. Alternatively, but not preferably, the vagina may bedissected and the member 66 or sling 42 directly accessed throughanother vaginal incision.

Referring to the alternate embodiment shown in FIG. 33, a small incisionis made in the perineal area 406 of a male patient. As with the femalepatient, two small transverse suprapubic incisions 400 are also made toallow for needle entry. After the handle 64 is securely attached andproperly positioned on the needle 60, the first end of the needle 60 ispassed through one of the suprapubic incisions 400, down the posteriorside of the pubic bone 402, through the endopelvic fascia and into theperineal incision 406. The user of the device utilizes the handle 64 toguide the needle 60 through the various tissues, avoiding major pubicvessels, the bladder 14 and prostate gland. The second needle 60 isinserted in a similar fashion on the contra-lateral side. A cystoscopyprocedure may be performed to confirm bladder integrity. The dilators 54and sling assembly 46 are then positioned under the target site, slingtension is adjusted and the remainder of the procedure is performedsimilar to that previously described for a female patient.

In another embodiment of the invention, the previously describedcystoscopy aids 54D (FIG. 14B) can be used in addition to, or optionallyin place of the cystoscopy procedure. Once both needles 60 are in place,the cystoscopy aids 54D are passed along the length of the needles 60.If the bladder has been punctured during needle insertion causing urineleakage within the patient, the urine enters the apertures 160 of thecystoscopy aids 54D, flows along the surface and out from the needle 60.Based on the configuration of the cystoscopy aids 54D and desiredtreatment/procedure, the cystoscopy aids 54D may be removed, the sling42 or sling assembly 46 may be attached to the cystoscopy aids 54D orthe sling 42/sling assembly 46 may be hidden within or pulled throughthe cystoscopy aids 54D. Preferably, the cystoscopic aids are acontrasting color (e.g. blue) to afford ready identification of blood orother leakage from the bladder or other structures.

In an alternate embodiment, the slidable handle 204 is used in place ofor in combination with the handle 64. As previously described, theslidable handle 204 is positioned in a locked configuration near thefirst end 58 of the needle 60 and handle 64 is positioned near thesecond end 62 the needle 60. The repositionable handle 204 may be usedas a stop to prevent inadvertent lurching of the needle 58 intosensitive tissue. As the needle 60 is inserted into the incision, theuser or practitioner pushes the needle 60 through the incision 400 usinghandle 64 and guides or maneuvers the needle 60 through the varioustissues and spaces using slidable handle 204. When the slidable handle204 comes in close proximity to the incision, the user unlocks thehandle 204 and slides the handle 204 along a length of the needle 60.The slidable handle 204 is thereby repositioned away from the incisionand closer to the first end 62 of the needle 60. Once properly located,the slidable handle 204 is then locked in place and the insertionprocedure continues. The unlocking, repositioning and locking actionsare repeated at the convenience and discretion of the surgeon until theneedle 60 is fully inserted. Thus, this embodiment provides a systemwith more controlled and precise maneuverability than prior artstructures.

In another embodiment of the invention, shown in FIGS. 34 through 36,one end of the needle 60 is initially passed through a vaginal incision404 and toward one of the suprapubic incisions 400. While inserting theneedles 60 initially through the vagina is not preferred, it is withinthe scope of the present invention as some surgeons may prefer thisapproach due to previous surgical training, custom or personalpreference. The handles 64 are used to push and precisely guide theneedle 60 through the various tissues, without perforating or damagingthe bowel and/or blood vessels. With the first needle 60 in place, asecond needle 60 may be inserted in the same way on a contra-lateralside. As before, a separate cystoscopy procedure may be performed toconfirm bladder integrity.

As shown in FIG. 35, the handles 64 are detached from one end of theneedles 60 and securely attached at the opposite ends of the needles 60protruding from the abdominal incision 400. In this configuration, auser of the device can use the same handles 64 to also withdraw theneedles 60 from the patient. Alternatively, the first pair of handles 64can be detached from the needles 60 protruding from the vagina anddiscarded. A second pair of new or different handles 64 can then beattached to the needles 60 protruding from the abdominal incision 400and used for the remainder of the procedure.

Referring to FIG. 36, the dilators 54 and sling assembly 46 are attachedto the ends of the needles 60 protruding from the vagina 20. Theremainder of the procedure is similar to that described in previousembodiments of the invention.

When using the embodiment of the present invention described inconjunction with FIGS. 34-36, additional attention is directed tokeeping the needles away from major pubic vessels, nerves and organssuch as the urethra, bowel and bladder. FIG. 38 is a schematic view of acadaver. FIG. 39 is an illustration of an opened cadaver showing, on theleft, a prior art TVT needle VA that was properly placed using aninitial vaginal approach; and on the right, a needle SPA properly placedaccording to a preferred embodiment of the present invention (using asuprapubic approach). The TVT procedure requires the surgeon to blindlypass a large diameter stainless steel trocar upward in a retrograde,retropubic fashion through the retropubic space to position a slingbeneath the urethra. The upward approach lacks anatomical guides toassist in positioning the needle in a path that is spaced from pelvicvessels, nerves, organs and sensitive tissue such as the urethra,bladder and bowel.

FIG. 40 is another view of the cadaver showing the TVT needle VAlaterally deviated from its proper path and the needle SPA laterallydeviated from its proper path. Because the vaginally inserted TVT needleVA is blindly passed upward through the retropubic space, it is believedthat the end E of the needle VA is more prone to injure pelvic vesselsand nerves 502 or even the bladder or bowel. In contrast, even if theend 58 of the needle SPA inserted according to a preferred embodiment ofthe present invention deviates slightly laterally as shown in FIG. 40,the surgeon may exploit the resistance provided by the posterior portionof the pelvic bone 402 to correct the path of the needle SPA back intothe preferred passage region 385 (FIG. 30A) and avoid the pelvic vesselsand nerves 504. This also helps reduce the risk of puncturing sensitivetissue such as that of the bladder, bowels and urethra.

As previously described, the device of the present invention can also beused for male patients. Just as the vaginal approach may be used forfemale patients, a perineal approach may be used for male patients. Oneend of a needle 60 is initially passed through a perineal incision 406and toward one of the suprapubic incisions 400. The insertion of thesecond needle 60 and the remainder of the procedure are similar to thatpreviously described.

In an alternate embodiment, sheath tags, center markers or other meansmay be used to aid the practitioner in accurately centering the sheath44 under the urethra or bladder neck in females or bulbar urethra inmales. Thus, end and/or center markings may be used as additional aidsfor separating the delivery system from the sling 42 and centrallyplacing the sling 42 at the target site.

In another embodiment of method according to the present invention, fourneedles may be utilized to implant the sling shown in FIG. 41. Theneedles may extend from four abdominal incisions to a vaginal incision.The sling 42P may be used as a hammock to support the bladder or forother procedures to address a cystocele or prolapse or a vaginal vaulttreatment.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A method of implanting a sling to treat urinaryincontinence in a female patient comprising the steps of: creating atleast one incision in the vaginal region of the patient, creating atleast one incision in the suprapubic region of the patient, providingfirst and second guide needles, creating a first pathway on a first sideof the patient's urethra by initially passing the distal end of thefirst needle through the incised suprapubic region and then passing thedistal end of the first needle through the incised vaginal region,creating a second pathway on a side of the patient's urethra generallyopposite the first side by initially passing the distal end of thesecond needle through the incised suprapubic region and then passing thedistal end of the second needle through the incised vaginal region,providing first and second connectors and a synthetic implantablematerial, each connector including a taper on the leading edge thereof,connecting one of the connectors to the distal end of the first needleafter the first needle emerges from the incised vaginal region,connecting the other connector to the distal end of the second needleafter the second needle emerges from the incised vaginal region, andmoving the distal ends of the first and second needles and theconnectors from the incised vaginal region toward the incised suprapubicregion to implant the implantable material in a therapeuticallyeffective position, wherein the moving step includes the step of,expanding the first and second pathways provided by the first and secondneedles with the tapered surfaces of the connectors.